Ramosetron

14,000,000 Leading Edge Experts on the ideXlab platform

Scan Science and Technology

Contact Leading Edge Experts & Companies

Scan Science and Technology

Contact Leading Edge Experts & Companies

The Experts below are selected from a list of 360 Experts worldwide ranked by ideXlab platform

Hiroyoshi Tanaka - One of the best experts on this subject based on the ideXlab platform.

  • retraction note to Ramosetron vs granisetron for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy
    Canadian Journal of Anaesthesia-journal Canadien D Anesthesie, 2013
    Co-Authors: Yoshitaka Fujii, Yuhji Saitoh, Hiroyoshi Tanaka, Hidenori Toyooka
    Abstract:

    To compare the efficacy of Ramosetron with granisetron for the prevention of postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy. In a randomized, double-blind study, 80 female inpatients received 3 mg granisetron or 0.3 mg Ramosetroniv (n=40 of each) at the completion of surgery The standardized anesthetic included isoflurane and nitrous oxide in oxygen. Complete response, defined as no PONV during the first 24 hr (0–24 hr) after anesthesia was 85% with granisetron and 93% with Ramosetron, respectively (P=0.241); the corresponding incidence during the next 24 hr (24–48 hr) after anesthesia was 63% and 90% (P=0.004). No clinically important adverse events due to the study drug were observed in any of the groups. Ramosetron was more effective than granisetron for prevention of PONV during 0–48 hr after anesthesia for laparoscopic cholecystectomy.

  • a randomized clinical trial of a single dose of Ramosetron for the prevention of vomiting after strabismus surgery in children a dose ranging study
    Archives of Ophthalmology, 2005
    Co-Authors: Yoshitaka Fujii, Hiroyoshi Tanaka, Mutsuko Ito
    Abstract:

    Background Postoperative vomiting (POV) after pediatric strabismus surgery remains a major problem. Objective To evaluate the efficacy and safety of a single dose of Ramosetron, a new serotonin antagonist, for preventing POV in children undergoing strabismus surgery. Method In a prospective, randomized, double-masked, placebo-controlled study, 80 children (38 boys and 42 girls), aged 4 to 10 years, scheduled for strabismus surgery, received intravenously either placebo or Ramosetron at 1 of 3 different doses (3 μg/kg, 6 μg/kg, or 12 μg/kg) (n = 20 each) at the end of the surgical procedure. A standard general anesthetic technique was used. Main Outcome Measures Emetic episodes were recorded and safety assessments performed during the first and second 24-hour periods (ie, 0-24 and 24-48 hours) after receiving anesthesia. Results The rate of patients who were emesis-free (defined as no retching and no vomiting), during the 0- to 24-hour period after anesthesia was 35% with 3 μg/kg of Ramosetron ( P  = .37), 90% with 6 μg/kg of Ramosetron ( P  = .001), and 90% with 12 μg/kg of Ramosetron ( P  = .001) compared with placebo (25%). The corresponding rate during the 24- to 48-hour period after anesthesia was 40% ( P  = .371), 90% ( P  = .001), and 90% ( P  = .001), respectively, compared with placebo (30%). No clinically important adverse events were observed in any group. Conclusions A 6-μg/kg dose of Ramosetron is sufficient, but a 3-μg/kg dose is insufficient for preventing POV during the 0- to 48-hour period after anesthesia in children undergoing strabismus surgery. Increasing the dose to 12 μg/kg of Ramosetron provides no demonstrable additional benefit.

  • benefits and risks of granisetron versus Ramosetron for nausea and vomiting after breast surgery a randomized double blinded placebo controlled trial
    American Journal of Therapeutics, 2004
    Co-Authors: Yoshitaka Fujii, Hiroyoshi Tanaka, Tsuneo Kawasaki
    Abstract:

    Women undergoing general anesthesia for breast surgery are at particular risk of postoperative nausea and vomiting. In a randomized, double-blinded, placebo-controlled trial, 90 patients scheduled for breast surgery, aged 33-63 years, received intravenously placebo, 3 mg granisetron, or 0.3 mg Ramosetron (n = 30 of each) at the end of surgical procedure. A standard general anesthetic technique and postoperative analgesia were used. Emetic episodes and safety assessment were performed during 0-24 hours and 24-48 hours after anesthesia. The rate of patients experiencing emetic symptoms (nausea, retching, vomiting) 0-24 hours after anesthesia was 17% with granisetron (P = 0.013) and 10% with Ramosetron (P = 0.002) compared with placebo (47%); the corresponding rate 24-48 hours after anesthesia was 27% (P = 0.032) and 7% (P = 0.001), compared with placebo (53%). In the 24-48 hours after anesthesia, there were fewer emetic episodes in patients who had received Ramosetron than in those who had received granisetron (P = 0.039). The severity of nausea was less in patients receiving Ramosetron than in those receiving granisetron (P = 0.044). Zero to 24 hours after anesthesia, no difference in the rate of patients having emetic symptoms and the severity of nausea was observed between the granisetron and Ramosetron groups. The most common reported adverse events were headache and dizziness, and there were no difference in the incidence of adverse events due to the study drug among the 3 groups. In conclusion, prophylactic therapy with Ramosetron is more effective than that with granisetron for the long-term prevention of postoperative nausea and vomiting in women undergoing general anesthesia for breast surgery.

  • randomized double blind placebo controlled dosed finding study of the antiemetic effects and tolerability of Ramosetron in adults undergoing middle ear surgery
    Clinical Therapeutics, 2003
    Co-Authors: Yoshitaka Fujii, Hiroyoshi Tanaka
    Abstract:

    Background: Ramosetron is a selective serotonin receptor antagonist (SSRA) that is approved for the treatment of emetic symptoms induced by cytotoxic drugs in Japan. We have reported that Ramosetron 0.3 mg had comparable efficacy to granisetron 3 mg, another SSRA, in preventing emetic symptoms in adults in the first 48 hours after the start of anesthesia for middle ear surgery. Although it has been shown that a high dose of Ramosetron can cause adverse effects (AEs), such as severe headache, the minimal effective dose of Ramosetron is unknown. Objective: The aim of this study was to determine the minimum effective and tolerable dose of Ramosetron needed to prevent postoperative emetic symptoms in adult patients undergoing middle ear surgery. Methods: This randomized, double-blind, placebo-controlled, dose-finding study was conducted at the Department of Anesthesiology, Toride Kyodo General Hospital (Toride, Japan). Patients aged ≥20 years scheduled for middle ear surgery were randomized to receive either placebo or Ramosetron at 1 of 3 doses (0.15, o.3, or 0.6 mg), regardless of body weight, IV immediately before anesthesia induction. Emetic symptoms (nausea, retching, or vomiting) occurring from 0 to <24 and 24 to 48 hours after the start of anesthesia were recorded. Other AEs also were assessed. Results: A total of 100 patients (55 women, 45 men; mean [SD] age, 44 [12] years; mean [SD] body weight, 56 [8] kg; mean [SD] height, 159 [8] cm) were enrolled. Each treatment group comprised 25 patients. The treatment groups were comparable with regard to demographic characteristics and type of surgery After the second 24 hour postanesthesia period, significantly more patients in the Ramosetron 0.3-mg and 0.6-mg groups were emesis free than in the placebo group (both P < 0.001). The number of emesis-free patients in the Ramosetron 0.15-mg group and the placebo group were similar after both study periods. No significant difference in antiemetic efficacy was found between the Ramosetron 0.3-mg and 0.6-mg groups. No relationship between body weight and the efficacy of Ramosetron was observed. The incidence of AEs was similar in all 4 groups. Conclusions: Ramosetron 0.3 mg, regardless of body weight, was more effective than either Ramosetron 0.15 mg or placebo and as effective as Ramosetron 0.6 mg for the prevention of emetic symptoms in the first 48 hours after the start of anesthesia in this selected population of adult patients who underwent middle ear surgery.

  • Double-blind, placebo-controlled, dose-ranging study of Ramosetron for the prevention of nausea and vomiting after thyroidectomy
    Clinical Therapeutics, 2002
    Co-Authors: Yoshitaka Fujii, Hiroyoshi Tanaka
    Abstract:

    Abstract Background: Patients receiving general anesthesia during thyroidectomy have a high risk for postoperative nausea and vomiting. Objective: This prospective, randomized, double-blind, placebo-controlled, dose-ranging study was undertaken to assess the efficacy and safety of Ramosetron, a selective 5-hydroxytryptamine type 3—receptor antagonist, in preventing nausea and vomiting after thyroidectomy. Methods: Standard general anesthetic technique and postoperative analgesia were employed. Patients undergoing thyroidectomy were randomized to receive IV Ramosetron 0.15, 0.3, or 0.6 mg or placebo at completion of the procedure. During the first 48 hours after anesthesia, episodes of emesis and adverse events were assessed by nursing staff who were blinded to patients' treatment assignment. Results: Eighty patients (22 men, 58 women; age range, 28–63 years; weight range, 37–91 kg) were enrolled in the study. There were no differences in demographic characteristics between treatment groups. The numbers of patients who were emesis free (no nausea, retching, or vomiting) 0 to 24 hours after anesthesia were 10 of 20 (50%) with Ramosetron 0.15 mg, 17 of 20 (85%) with Ramosetron 0.3 mg, 18 of 20 (90%) with Ramosetron 0.6 mg, and 8 of 20 (40%) with placebo. The corresponding numbers 24 to 48 hours after anesthesia were 11 of 20 (55%), 18 of 20 (90%), 18 of 20 (90%), and 9 of 20 (45%). At both time points, only the values for Ramosetron 0.3 and 0.6 mg were statistically significant versus placebo ( P ≤ 0.001). No clinically serious adverse events were observed in any group. Conclusions: In this population of patients receiving general anesthesia while undergoing thyroidectomy, Ramosetron 0.3 mg was effective in preventing postoperative nausea and vomiting 0 to 48 hours after anesthesia. Increasing the dose to 0.6 mg provided no demonstrable benefit.

Yoshitaka Fujii - One of the best experts on this subject based on the ideXlab platform.

  • retraction note to Ramosetron vs granisetron for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy
    Canadian Journal of Anaesthesia-journal Canadien D Anesthesie, 2013
    Co-Authors: Yoshitaka Fujii, Yuhji Saitoh, Hiroyoshi Tanaka, Hidenori Toyooka
    Abstract:

    To compare the efficacy of Ramosetron with granisetron for the prevention of postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy. In a randomized, double-blind study, 80 female inpatients received 3 mg granisetron or 0.3 mg Ramosetroniv (n=40 of each) at the completion of surgery The standardized anesthetic included isoflurane and nitrous oxide in oxygen. Complete response, defined as no PONV during the first 24 hr (0–24 hr) after anesthesia was 85% with granisetron and 93% with Ramosetron, respectively (P=0.241); the corresponding incidence during the next 24 hr (24–48 hr) after anesthesia was 63% and 90% (P=0.004). No clinically important adverse events due to the study drug were observed in any of the groups. Ramosetron was more effective than granisetron for prevention of PONV during 0–48 hr after anesthesia for laparoscopic cholecystectomy.

  • a randomized clinical trial of a single dose of Ramosetron for the prevention of vomiting after strabismus surgery in children a dose ranging study
    Archives of Ophthalmology, 2005
    Co-Authors: Yoshitaka Fujii, Hiroyoshi Tanaka, Mutsuko Ito
    Abstract:

    Background Postoperative vomiting (POV) after pediatric strabismus surgery remains a major problem. Objective To evaluate the efficacy and safety of a single dose of Ramosetron, a new serotonin antagonist, for preventing POV in children undergoing strabismus surgery. Method In a prospective, randomized, double-masked, placebo-controlled study, 80 children (38 boys and 42 girls), aged 4 to 10 years, scheduled for strabismus surgery, received intravenously either placebo or Ramosetron at 1 of 3 different doses (3 μg/kg, 6 μg/kg, or 12 μg/kg) (n = 20 each) at the end of the surgical procedure. A standard general anesthetic technique was used. Main Outcome Measures Emetic episodes were recorded and safety assessments performed during the first and second 24-hour periods (ie, 0-24 and 24-48 hours) after receiving anesthesia. Results The rate of patients who were emesis-free (defined as no retching and no vomiting), during the 0- to 24-hour period after anesthesia was 35% with 3 μg/kg of Ramosetron ( P  = .37), 90% with 6 μg/kg of Ramosetron ( P  = .001), and 90% with 12 μg/kg of Ramosetron ( P  = .001) compared with placebo (25%). The corresponding rate during the 24- to 48-hour period after anesthesia was 40% ( P  = .371), 90% ( P  = .001), and 90% ( P  = .001), respectively, compared with placebo (30%). No clinically important adverse events were observed in any group. Conclusions A 6-μg/kg dose of Ramosetron is sufficient, but a 3-μg/kg dose is insufficient for preventing POV during the 0- to 48-hour period after anesthesia in children undergoing strabismus surgery. Increasing the dose to 12 μg/kg of Ramosetron provides no demonstrable additional benefit.

  • benefits and risks of granisetron versus Ramosetron for nausea and vomiting after breast surgery a randomized double blinded placebo controlled trial
    American Journal of Therapeutics, 2004
    Co-Authors: Yoshitaka Fujii, Hiroyoshi Tanaka, Tsuneo Kawasaki
    Abstract:

    Women undergoing general anesthesia for breast surgery are at particular risk of postoperative nausea and vomiting. In a randomized, double-blinded, placebo-controlled trial, 90 patients scheduled for breast surgery, aged 33-63 years, received intravenously placebo, 3 mg granisetron, or 0.3 mg Ramosetron (n = 30 of each) at the end of surgical procedure. A standard general anesthetic technique and postoperative analgesia were used. Emetic episodes and safety assessment were performed during 0-24 hours and 24-48 hours after anesthesia. The rate of patients experiencing emetic symptoms (nausea, retching, vomiting) 0-24 hours after anesthesia was 17% with granisetron (P = 0.013) and 10% with Ramosetron (P = 0.002) compared with placebo (47%); the corresponding rate 24-48 hours after anesthesia was 27% (P = 0.032) and 7% (P = 0.001), compared with placebo (53%). In the 24-48 hours after anesthesia, there were fewer emetic episodes in patients who had received Ramosetron than in those who had received granisetron (P = 0.039). The severity of nausea was less in patients receiving Ramosetron than in those receiving granisetron (P = 0.044). Zero to 24 hours after anesthesia, no difference in the rate of patients having emetic symptoms and the severity of nausea was observed between the granisetron and Ramosetron groups. The most common reported adverse events were headache and dizziness, and there were no difference in the incidence of adverse events due to the study drug among the 3 groups. In conclusion, prophylactic therapy with Ramosetron is more effective than that with granisetron for the long-term prevention of postoperative nausea and vomiting in women undergoing general anesthesia for breast surgery.

  • randomized double blind placebo controlled dosed finding study of the antiemetic effects and tolerability of Ramosetron in adults undergoing middle ear surgery
    Clinical Therapeutics, 2003
    Co-Authors: Yoshitaka Fujii, Hiroyoshi Tanaka
    Abstract:

    Background: Ramosetron is a selective serotonin receptor antagonist (SSRA) that is approved for the treatment of emetic symptoms induced by cytotoxic drugs in Japan. We have reported that Ramosetron 0.3 mg had comparable efficacy to granisetron 3 mg, another SSRA, in preventing emetic symptoms in adults in the first 48 hours after the start of anesthesia for middle ear surgery. Although it has been shown that a high dose of Ramosetron can cause adverse effects (AEs), such as severe headache, the minimal effective dose of Ramosetron is unknown. Objective: The aim of this study was to determine the minimum effective and tolerable dose of Ramosetron needed to prevent postoperative emetic symptoms in adult patients undergoing middle ear surgery. Methods: This randomized, double-blind, placebo-controlled, dose-finding study was conducted at the Department of Anesthesiology, Toride Kyodo General Hospital (Toride, Japan). Patients aged ≥20 years scheduled for middle ear surgery were randomized to receive either placebo or Ramosetron at 1 of 3 doses (0.15, o.3, or 0.6 mg), regardless of body weight, IV immediately before anesthesia induction. Emetic symptoms (nausea, retching, or vomiting) occurring from 0 to <24 and 24 to 48 hours after the start of anesthesia were recorded. Other AEs also were assessed. Results: A total of 100 patients (55 women, 45 men; mean [SD] age, 44 [12] years; mean [SD] body weight, 56 [8] kg; mean [SD] height, 159 [8] cm) were enrolled. Each treatment group comprised 25 patients. The treatment groups were comparable with regard to demographic characteristics and type of surgery After the second 24 hour postanesthesia period, significantly more patients in the Ramosetron 0.3-mg and 0.6-mg groups were emesis free than in the placebo group (both P < 0.001). The number of emesis-free patients in the Ramosetron 0.15-mg group and the placebo group were similar after both study periods. No significant difference in antiemetic efficacy was found between the Ramosetron 0.3-mg and 0.6-mg groups. No relationship between body weight and the efficacy of Ramosetron was observed. The incidence of AEs was similar in all 4 groups. Conclusions: Ramosetron 0.3 mg, regardless of body weight, was more effective than either Ramosetron 0.15 mg or placebo and as effective as Ramosetron 0.6 mg for the prevention of emetic symptoms in the first 48 hours after the start of anesthesia in this selected population of adult patients who underwent middle ear surgery.

  • Double-blind, placebo-controlled, dose-ranging study of Ramosetron for the prevention of nausea and vomiting after thyroidectomy
    Clinical Therapeutics, 2002
    Co-Authors: Yoshitaka Fujii, Hiroyoshi Tanaka
    Abstract:

    Abstract Background: Patients receiving general anesthesia during thyroidectomy have a high risk for postoperative nausea and vomiting. Objective: This prospective, randomized, double-blind, placebo-controlled, dose-ranging study was undertaken to assess the efficacy and safety of Ramosetron, a selective 5-hydroxytryptamine type 3—receptor antagonist, in preventing nausea and vomiting after thyroidectomy. Methods: Standard general anesthetic technique and postoperative analgesia were employed. Patients undergoing thyroidectomy were randomized to receive IV Ramosetron 0.15, 0.3, or 0.6 mg or placebo at completion of the procedure. During the first 48 hours after anesthesia, episodes of emesis and adverse events were assessed by nursing staff who were blinded to patients' treatment assignment. Results: Eighty patients (22 men, 58 women; age range, 28–63 years; weight range, 37–91 kg) were enrolled in the study. There were no differences in demographic characteristics between treatment groups. The numbers of patients who were emesis free (no nausea, retching, or vomiting) 0 to 24 hours after anesthesia were 10 of 20 (50%) with Ramosetron 0.15 mg, 17 of 20 (85%) with Ramosetron 0.3 mg, 18 of 20 (90%) with Ramosetron 0.6 mg, and 8 of 20 (40%) with placebo. The corresponding numbers 24 to 48 hours after anesthesia were 11 of 20 (55%), 18 of 20 (90%), 18 of 20 (90%), and 9 of 20 (45%). At both time points, only the values for Ramosetron 0.3 and 0.6 mg were statistically significant versus placebo ( P ≤ 0.001). No clinically serious adverse events were observed in any group. Conclusions: In this population of patients receiving general anesthesia while undergoing thyroidectomy, Ramosetron 0.3 mg was effective in preventing postoperative nausea and vomiting 0 to 48 hours after anesthesia. Increasing the dose to 0.6 mg provided no demonstrable benefit.

Kei Matsueda - One of the best experts on this subject based on the ideXlab platform.

  • optimal dose of Ramosetron in female patients with irritable bowel syndrome with diarrhea a randomized placebo controlled phase ii study
    Neurogastroenterology and Motility, 2017
    Co-Authors: Shin Fukudo, Hiraku Akiho, Ken Haruma, Yoshihiro Nakashima, Kei Matsueda, Motoko Ida, H Hayase, Michio Hongo
    Abstract:

    BACKGROUND Previous studies showed that 5 μg of Ramosetron, a serotonin (5-hydroxytryptamine: 5-HT)-3 receptor antagonist, is only effective in male patients with irritable bowel syndrome (IBS) with diarrhea (IBS-D). We hypothesized that either dose 1.25, 2.5, or 5 μg of Ramosetron would be effective in female patients with IBS-D. METHODS This randomized, double-blind, placebo-controlled, phase II dose-finding exploratory trial included 409 female outpatients with IBS-D treated in Japan. They were administered oral placebo (n=102), or 1.25 μg (n=104), 2.5 μg (n=104), or 5 μg (n=99) of Ramosetron once daily for 12 weeks after a 1-week baseline period. The primary endpoint was monthly responder rates of global improvement of IBS symptoms in the first month. Secondary endpoints included global improvement in the other months, abdominal pain/discomfort, weekly mean changes in the Bristol Stool Form Scale (BSFS), and IBS-QOL. KEY RESULTS Middle dose (2.5 μg) of Ramosetron significantly improved abdominal pain/discomfort at second month (62.5%, P=.002), third month (60.6%, P=.005), and the last evaluation point (63.5%, P=.002) and weekly BSFS (P<.05) except at Week 8, 11, and 12 than placebo. IBS-QOL did not change. Ramosetron induced more constipation than placebo. CONCLUSIONS & INFERENCES The trial suggested that 2.5 μg of Ramosetron is the most effective and least harmful option for treating female patients with IBS-D (Clinicaltrials.gov ID: NCT01274000).

  • randomized placebo controlled phase iv pilot study of Ramosetron to evaluate the co primary end points in male patients with irritable bowel syndrome with diarrhea
    Biopsychosocial Medicine, 2017
    Co-Authors: Motoko Ida, Hiraku Akiho, Akito Nishida, Yoshihiro Nakashima, Kei Matsueda, Shin Fukudo
    Abstract:

    Global assessment allows patients to assess improvement in multiple irritable bowel syndrome (IBS) symptoms. However, it was deemed important to assess “clinically meaningful improvements, focusing on the patient’s chief complaint and the severity of major IBS symptoms” in addition to global assessment to show how Ramosetron is effective for individual IBS symptoms. This is a pilot study to explore clinical endpoints focusing on the chief complaint of patients with IBS with diarrhea (IBS-D). The same database was used in a previously reported post-marketing phase IV, randomized placebo-controlled pilot trial in male patients with IBS-D. The hypothesis is completely different from that of the other study. Patients with IBS-D diagnosed according to Rome III criteria were given either 5 μg of Ramosetron (n = 47) or placebo (n = 51) once daily for 12 weeks after a one-week baseline period. To explore and examine endpoints that allow evaluation of “clinically meaningful improvements focusing on the patient’s chief complaint,” the chief complaint and its relief by this study drug were assessed in this exploratory study. Rates of patients with abdominal pain/discomfort, stool form and stool frequency which patients had as a chief complaint before administration were 34.0, 19.1 and 25.5%, respectively, in the Ramosetron 5 μg group and 42.0, 18.0, and 20.0% in the placebo group. Responder rates for improvement in symptoms of the chief complaint that patients had before administration were 53.2% in the Ramosetron 5 μg group and 42.0% in the placebo group at the last point. The greatest symptomatic improvement in the chief complaint in the Ramosetron 5 μg group compared to the placebo group was shown with respect to stool consistency. Bristol Stool Form Scale (BSFS) scores were significantly lower in the Ramosetron group than in the placebo group (4.36 ± 1.195 vs 4.85 ± 0.890 at the last point, P = 0.027) throughout the treatment period, except at week 6. Ramosetron acted most effectively on stool consistency. Improvement in stool consistency is considered to be a clinically meaningful endpoint in showing how Ramosetron was effective for individual IBS symptoms. (Clinicaltrials.gov ID: NCT00918411. Registered 9 June 2009).

  • effect of Ramosetron on stool consistency in male patients with irritable bowel syndrome with diarrhea
    Clinical Gastroenterology and Hepatology, 2014
    Co-Authors: Shin Fukudo, Hiraku Akiho, Yoshihiro Nakashima, Motoko Ida, Kei Matsueda
    Abstract:

    Background & Aims Ramosetron, a serotonin (5-hydroxytryptamine)-3 receptor antagonist with high selectivity, reduced stress-induced diarrhea and defecation caused by corticotropin-releasing hormone in rats. However, there have been no clinical trials of its effect in patients with diarrhea and irritable bowel syndrome (IBS-D). We performed a randomized, double-blind, placebo-controlled trial to determine whether Ramosetron reduces diarrhea in these patients. Methods Our study included 296 male outpatients with IBS-D treated at 52 centers in Japan. Patients were given 5 μg oral Ramosetron (n = 147) or placebo (n = 149) once daily for 12 weeks after a 1-week baseline period. The primary end point was increased stool consistency in the first month. Secondary end points included relief of overall IBS symptoms and increased IBS-related quality of life. Results More patients given Ramosetron (74, 50.3%) than those given placebo (29, 19.6%) reported improved stool consistency in the first month ( P Conclusions Ramosetron (5 μg oral, once daily for 12 weeks) improved stool consistency in male patients with IBS-D, compared with placebo. These study results, along with the pharmacologic profile of Ramosetron, indicate that increased stool consistency is the best end point for studies of Ramosetron in patients with IBS-D. Clinicaltrials.gov No, NCT01225237.

  • a randomized double blind placebo controlled clinical trial of the effectiveness of the novel serotonin type 3 receptor antagonist Ramosetron in both male and female japanese patients with diarrhea predominant irritable bowel syndrome
    Scandinavian Journal of Gastroenterology, 2008
    Co-Authors: Kei Matsueda, Shigeru Harasawa, Michio Hongo, Nobuo Hiwatashi, Daisuke Sasaki
    Abstract:

    Objective. Irritable bowel syndrome is characterized by abdominal discomfort and/or pain associated with altered bowel habits. The neurotransmitter serotonin and serotonin type 3 receptors that are extensively distributed on enteric neurons in the human gastrointestinal tract play a role in increasing the sensation of pain and affecting bowel habits in patients with irritable bowel syndrome. The aim of this study was to evaluate the efficacy and safety of the serotonin type 3 receptor antagonist Ramosetron hydrochloride in Japanese patients with diarrhea-predominant irritable bowel syndrome. Material and methods. In a double-blind, placebo-controlled, parallel group-comparative study with a 1-week run-in period, 539 patients with diarrhea-predominant irritable bowel syndrome meeting the Rome II diagnostic criteria received either 5 µg Ramosetron hydrochloride (n=270) or placebo (n=269) once daily for 12 weeks. Results. Forty-seven percent of Ramosetron hydrochloride-treated patients were monthly responder...

Shin Fukudo - One of the best experts on this subject based on the ideXlab platform.

  • optimal dose of Ramosetron in female patients with irritable bowel syndrome with diarrhea a randomized placebo controlled phase ii study
    Neurogastroenterology and Motility, 2017
    Co-Authors: Shin Fukudo, Hiraku Akiho, Ken Haruma, Yoshihiro Nakashima, Kei Matsueda, Motoko Ida, H Hayase, Michio Hongo
    Abstract:

    BACKGROUND Previous studies showed that 5 μg of Ramosetron, a serotonin (5-hydroxytryptamine: 5-HT)-3 receptor antagonist, is only effective in male patients with irritable bowel syndrome (IBS) with diarrhea (IBS-D). We hypothesized that either dose 1.25, 2.5, or 5 μg of Ramosetron would be effective in female patients with IBS-D. METHODS This randomized, double-blind, placebo-controlled, phase II dose-finding exploratory trial included 409 female outpatients with IBS-D treated in Japan. They were administered oral placebo (n=102), or 1.25 μg (n=104), 2.5 μg (n=104), or 5 μg (n=99) of Ramosetron once daily for 12 weeks after a 1-week baseline period. The primary endpoint was monthly responder rates of global improvement of IBS symptoms in the first month. Secondary endpoints included global improvement in the other months, abdominal pain/discomfort, weekly mean changes in the Bristol Stool Form Scale (BSFS), and IBS-QOL. KEY RESULTS Middle dose (2.5 μg) of Ramosetron significantly improved abdominal pain/discomfort at second month (62.5%, P=.002), third month (60.6%, P=.005), and the last evaluation point (63.5%, P=.002) and weekly BSFS (P<.05) except at Week 8, 11, and 12 than placebo. IBS-QOL did not change. Ramosetron induced more constipation than placebo. CONCLUSIONS & INFERENCES The trial suggested that 2.5 μg of Ramosetron is the most effective and least harmful option for treating female patients with IBS-D (Clinicaltrials.gov ID: NCT01274000).

  • randomized placebo controlled phase iv pilot study of Ramosetron to evaluate the co primary end points in male patients with irritable bowel syndrome with diarrhea
    Biopsychosocial Medicine, 2017
    Co-Authors: Motoko Ida, Hiraku Akiho, Akito Nishida, Yoshihiro Nakashima, Kei Matsueda, Shin Fukudo
    Abstract:

    Global assessment allows patients to assess improvement in multiple irritable bowel syndrome (IBS) symptoms. However, it was deemed important to assess “clinically meaningful improvements, focusing on the patient’s chief complaint and the severity of major IBS symptoms” in addition to global assessment to show how Ramosetron is effective for individual IBS symptoms. This is a pilot study to explore clinical endpoints focusing on the chief complaint of patients with IBS with diarrhea (IBS-D). The same database was used in a previously reported post-marketing phase IV, randomized placebo-controlled pilot trial in male patients with IBS-D. The hypothesis is completely different from that of the other study. Patients with IBS-D diagnosed according to Rome III criteria were given either 5 μg of Ramosetron (n = 47) or placebo (n = 51) once daily for 12 weeks after a one-week baseline period. To explore and examine endpoints that allow evaluation of “clinically meaningful improvements focusing on the patient’s chief complaint,” the chief complaint and its relief by this study drug were assessed in this exploratory study. Rates of patients with abdominal pain/discomfort, stool form and stool frequency which patients had as a chief complaint before administration were 34.0, 19.1 and 25.5%, respectively, in the Ramosetron 5 μg group and 42.0, 18.0, and 20.0% in the placebo group. Responder rates for improvement in symptoms of the chief complaint that patients had before administration were 53.2% in the Ramosetron 5 μg group and 42.0% in the placebo group at the last point. The greatest symptomatic improvement in the chief complaint in the Ramosetron 5 μg group compared to the placebo group was shown with respect to stool consistency. Bristol Stool Form Scale (BSFS) scores were significantly lower in the Ramosetron group than in the placebo group (4.36 ± 1.195 vs 4.85 ± 0.890 at the last point, P = 0.027) throughout the treatment period, except at week 6. Ramosetron acted most effectively on stool consistency. Improvement in stool consistency is considered to be a clinically meaningful endpoint in showing how Ramosetron was effective for individual IBS symptoms. (Clinicaltrials.gov ID: NCT00918411. Registered 9 June 2009).

  • effect of Ramosetron in female patients with irritable bowel syndrome with diarrhea a phase iii long term study
    Journal of Gastroenterology, 2016
    Co-Authors: Shin Fukudo, Hiraku Akiho, Toshikatsu Okumura, Yoshikazu Kinoshita, Yoshihiro Nakashima, Motoko Ida, Kenta Hayashi, Ken Haruma
    Abstract:

    The long-term safety of administration of Ramosetron in female patients with irritable bowel syndrome with diarrhea (IBS-D) is unknown. The aim of this study was to assess the long-term safety, tolerability, and outcomes with the use of Ramosetron in female patients with IBS-D. This was a phase III, open-label, uncontrolled, long-term safety trial of the treatment of female Japanese patients with IBS-D, diagnosed according to the Rome III criteria. A total of 151 patients were given 2.5 μg of Ramosetron for 4 weeks, and responders continued the same dose for another 48 weeks. Non-responders at 4 weeks were given 5 μg of Ramosetron for 48 weeks. At the end of week 52, 106 patients receiving 2.5 μg and 17 patients receiving 5 μg had completed the study. Safety and efficacy including symptoms and quality of life (QOL) were evaluated. Concerning safety, no serious adverse event related to Ramosetron, specifically ischemic colitis, was observed in patients with either dose of Ramosetron. However, constipation occurred in 19.7 % of patients given 2.5 μg and 10.5 % of patients given 5 μg of Ramosetron. Ramosetron-treated patients showed high rates of global improvement. Stool consistency, abdominal pain and discomfort, and IBS-QOL were also improved at the last evaluation point. The results provide evidence of the long-term safety and efficacy of treatment with 2.5 and 5 μg of Ramosetron in female patients with IBS-D. Clinicians should be aware that one-fifth of women with IBS-D receiving Ramosetron may suffer from constipation during treatment (ClinicalTrials.gov ID: NCT01736423).

  • Ramosetron Reduces Symptoms of Irritable Bowel Syndrome With Diarrhea and Improves Quality of Life in Women
    Gastroenterology, 2015
    Co-Authors: Shin Fukudo, Hiraku Akiho, Akito Nishida, Toshikatsu Okumura, Yoshikazu Kinoshita, Yoshihiro Nakashima, Ken Haruma
    Abstract:

    Background & Aims Previous studies have indicated that serotonin-3–receptor antagonists might have a sex-specific effect in patients with irritable bowel syndrome with diarrhea (IBS-D). Alosetron has been approved for the treatment of only women, and Ramosetron has been approved for the treatment for only men. We performed a randomized, placebo-controlled, phase 3 study to determine whether Ramosetron reduces symptoms of IBS-D in women. Methods We performed a prospective study of 576 female outpatients with IBS-D (according to the Rome III criteria), from February 2013 through February 2014, at 70 academic Gastroenterology Departments in Japan. After a 1-week baseline period, subjects received either 2.5 μg Ramosetron (n = 292) or placebo (n = 284) once daily for 12 weeks. Primary end points were the monthly rates of response for relief from overall IBS symptoms and increased stool consistency at the last evaluation point. Quality of life (QOL) also was quantified. Results A significantly higher proportion of patients given Ramosetron reported global improvement (50.7%; 95% confidence interval [CI], 44.8–56.6) than patients given placebo (32.0%; 95% CI, 26.7–37.8)—a difference of 18.6% (95% CI, 10.7–26.5; P P P  = .001) and greater improvement in QOL ( P  = .002) compared with placebo. Ramosetron induced constipation in 11.0% of patients. Conclusions In a randomized, placebo-controlled study of 576 women with IBS-D, 2.5 μg Ramosetron per day reduced symptoms and increased stool consistency and QOL. Clinicaltrials.gov no: NCT01870895.

  • effect of Ramosetron on stool consistency in male patients with irritable bowel syndrome with diarrhea
    Clinical Gastroenterology and Hepatology, 2014
    Co-Authors: Shin Fukudo, Hiraku Akiho, Yoshihiro Nakashima, Motoko Ida, Kei Matsueda
    Abstract:

    Background & Aims Ramosetron, a serotonin (5-hydroxytryptamine)-3 receptor antagonist with high selectivity, reduced stress-induced diarrhea and defecation caused by corticotropin-releasing hormone in rats. However, there have been no clinical trials of its effect in patients with diarrhea and irritable bowel syndrome (IBS-D). We performed a randomized, double-blind, placebo-controlled trial to determine whether Ramosetron reduces diarrhea in these patients. Methods Our study included 296 male outpatients with IBS-D treated at 52 centers in Japan. Patients were given 5 μg oral Ramosetron (n = 147) or placebo (n = 149) once daily for 12 weeks after a 1-week baseline period. The primary end point was increased stool consistency in the first month. Secondary end points included relief of overall IBS symptoms and increased IBS-related quality of life. Results More patients given Ramosetron (74, 50.3%) than those given placebo (29, 19.6%) reported improved stool consistency in the first month ( P Conclusions Ramosetron (5 μg oral, once daily for 12 weeks) improved stool consistency in male patients with IBS-D, compared with placebo. These study results, along with the pharmacologic profile of Ramosetron, indicate that increased stool consistency is the best end point for studies of Ramosetron in patients with IBS-D. Clinicaltrials.gov No, NCT01225237.

Hidenori Toyooka - One of the best experts on this subject based on the ideXlab platform.

  • retraction note to Ramosetron vs granisetron for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy
    Canadian Journal of Anaesthesia-journal Canadien D Anesthesie, 2013
    Co-Authors: Yoshitaka Fujii, Yuhji Saitoh, Hiroyoshi Tanaka, Hidenori Toyooka
    Abstract:

    To compare the efficacy of Ramosetron with granisetron for the prevention of postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy. In a randomized, double-blind study, 80 female inpatients received 3 mg granisetron or 0.3 mg Ramosetroniv (n=40 of each) at the completion of surgery The standardized anesthetic included isoflurane and nitrous oxide in oxygen. Complete response, defined as no PONV during the first 24 hr (0–24 hr) after anesthesia was 85% with granisetron and 93% with Ramosetron, respectively (P=0.241); the corresponding incidence during the next 24 hr (24–48 hr) after anesthesia was 63% and 90% (P=0.004). No clinically important adverse events due to the study drug were observed in any of the groups. Ramosetron was more effective than granisetron for prevention of PONV during 0–48 hr after anesthesia for laparoscopic cholecystectomy.

  • Ramosetron for preventing postoperative nausea and vomiting in women undergoing gynecological surgery
    Anesthesia & Analgesia, 2000
    Co-Authors: Yoshitaka Fujii, Yuhji Saitoh, Hiroyoshi Tanaka, Hidenori Toyooka
    Abstract:

    In a prospective, randomized, double-blinded, placebo-controlled trial, we evaluated the efficacy of Ramosetron at three different doses (0.15, 0.3, and 0.6 mg) for the prevention of postoperative nausea and vomiting (PONV) after gynecological surgery. One hundred twenty women, ASA physical status I

  • Ramosetron vs granisetron for the prevention of postoperative nausea and vomiting after laparoscopic cholecystectomy
    Canadian Journal of Anaesthesia-journal Canadien D Anesthesie, 1999
    Co-Authors: Yoshitaka Fujii, Yuhji Saitoh, Hiroyoshi Tanaka, Hidenori Toyooka
    Abstract:

    Purpose To compare the efficacy of Ramosetron with granisetron for the prevention of postoperative nausea and vomiting (PONV) after laparoscopic cholecystectomy.

  • comparison of Ramosetron and granisetron for preventing postoperative nausea and vomiting after gynecologic surgery
    Anesthesia & Analgesia, 1999
    Co-Authors: Yoshitaka Fujii, Yuhji Saitoh, Hiroyoshi Tanaka, Hidenori Toyooka
    Abstract:

    UNLABELLED In a prospective, randomized, double-blinded study, we evaluated the efficacy of granisetron and Ramosetron for preventing postoperative nausea and vomiting (PONV) in major gynecologic surgery. One hundred twenty patients, ASA physical status I or II, aged 23-65 yr, received i.v. granisetron 2.5 mg or Ramosetron 0.3 mg (n = 60 each) at the end of surgery. A standard general anesthetic technique and postoperative analgesia were used. The incidence of a complete response, defined as no PONV and no need for another rescue medication, 0-3 h after anesthesia was 87% with granisetron and 90% with Ramosetron; the corresponding incidence 3-24 h after anesthesia was 85% and 90%; the corresponding incidence 24-48 h after anesthesia was 70% and 92% (P < 0.05). No clinically serious adverse events due to the drugs were observed in any of the groups. In conclusion, prophylactic therapy with Ramosetron is more effective than granisetron for the longterm prevention of PONV after major gynecologic surgery. IMPLICATIONS We compared the efficacy of granisetron and Ramosetron for preventing postoperative nausea and vomiting in major gynecologic surgery. Prophylactic therapy with Ramosetron was more effective than granisetron for preventing postoperative nausea and vomiting 24-48 h after anesthesia.