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Bernard P. Schachtel - One of the best experts on this subject based on the ideXlab platform.
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efficacy of flurbiprofen 8 75 mg Lozenge in patients with a swollen and inflamed sore throat
Current Medical Research and Opinion, 2016Co-Authors: Sue Aspley, Adrian Shephard, E Schachtel, K Sanner, Laurie Savino, Bernard P. SchachtelAbstract:AbstractObjective: Sore throat is often over-treated with antibiotics, therefore there is a need for non-antibiotic treatments that provide effective relief. From the patient’s point of view, symptoms of pharyngeal inflammation such as a “swollen” and “inflamed” throat are often considered the most bothersome; so, a non-steroidal anti-inflammatory drug could be an appropriate treatment. We investigated the efficacy and safety of flurbiprofen 8.75 mg Lozenge in adults with a swollen and inflamed throat.Research design and methods: We enrolled adults with moderate-to-severe sore throat and evidence of tonsillo-pharyngitis into a randomized, double-blind study. Patients received flurbiprofen 8.75 mg or placebo Lozenges every 3–6 hours as needed (up to five Lozenges in 24 hours) and rated their symptoms (sore throat pain, difficulty swallowing and the sensation of a swollen throat) on standard linear scales regularly over 24 hours. The efficacy of flurbiprofen Lozenge was determined in patients reporting a sw...
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randomised double blind placebo controlled studies on flurbiprofen 8 75 mg Lozenges in patients with without group a or c streptococcal throat infection with an assessment of clinicians prediction of strep throat
International Journal of Clinical Practice, 2015Co-Authors: Adrian Shephard, G Smith, S Aspley, Bernard P. SchachtelAbstract:SummaryBackground Diagnosing group A streptococcus (Strep A) throat infection by clinical examination is difficult, and misdiagnosis may lead to inappropriate antibiotic use. Most patients with sore throat seek symptom relief rather than antibiotics, therefore, therapies that relieve symptoms should be recommended to patients. We report two clinical trials on the efficacy and safety of flurbiprofen 8.75 mg Lozenge in patients with and without streptococcal sore throat. Methods The studies enrolled adults with moderate-to-severe throat symptoms (sore throat pain, difficulty swallowing and swollen throat) and a diagnosis of pharyngitis. The practitioner assessed the likelihood of Strep A infection based on historical and clinical findings. Patients were randomised to flurbiprofen 8.75 mg or placebo Lozenges under double-blind conditions and reported the three throat symptoms at baseline and at regular intervals over 24 h. Results A total of 402 patients received study medication (n = 203 flurbiprofen, n = 199 placebo). Throat culture identified Strep A in 10.0% of patients and group C streptococcus (Strep C) in a further 14.0%. The practitioners' assessments correctly diagnosed Strep A in 11/40 cases (sensitivity 27.5%, and specificity 79.7%). A single flurbiprofen Lozenge provided significantly greater relief than placebo for all three throat symptoms, lasting 3–4 h for patients with and without Strep A/C. Multiple doses of flurbiprofen Lozenges over 24 h also led to symptom relief, although not statistically significant in the Strep A/C group. There were no serious adverse events. Conclusions The results highlight the challenge of identifying Strep A based on clinical features. With the growing problem of antibiotic resistance, non-antibiotic treatments should be considered. As demonstrated here, flurbiprofen 8.75 mg Lozenges are an effective therapeutic option, providing immediate and long-lasting symptom relief in patients with and without Strep A/C infection.
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utility of the sore throat pain model in a multiple dose assessment of the acute analgesic flurbiprofen a randomized controlled study
Trials, 2014Co-Authors: Bernard P. Schachtel, Adrian Shephard, Sue Aspley, Tim Shea, Gary Smith, E SchachtelAbstract:The sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials. The model used here was designed to study the multiple-dose safety and efficacy of Lozenges containing flurbiprofen at 8.75 mg. Adults (n = 198) with moderate or severe acute sore throat and findings of pharyngitis on a Tonsillo-Pharyngitis Assessment (TPA) were randomly assigned to use either flurbiprofen 8.75 mg Lozenges (n = 101) or matching placebo Lozenges (n = 97) under double-blind conditions. Patients sucked one Lozenge every three to six hours as needed, up to five Lozenges per day, and rated symptoms on 100-mm scales: the Sore Throat Pain Intensity Scale (STPIS), the Difficulty Swallowing Scale (DSS), and the Swollen Throat Scale (SwoTS). Reductions in pain (lasting for three hours) and in difficulty swallowing and throat swelling (for four hours) were observed after a single dose of the flurbiprofen 8.75 mg Lozenge (P <0.05 compared with placebo). After using multiple doses over 24 hours, flurbiprofen-treated patients experienced a 59% greater reduction in throat pain, 45% less difficulty swallowing, and 44% less throat swelling than placebo-treated patients (all P <0.01). There were no serious adverse events. Utilizing the sore throat pain model with multiple doses over 24 hours, flurbiprofen 8.75 mg Lozenges were shown to be an effective, well-tolerated treatment for sore throat pain. Other pharmacologic actions (reduced difficulty swallowing and reduced throat swelling) and overall patient satisfaction from the flurbiprofen Lozenges were also demonstrated in this multiple-dose implementation of the sore throat pain model. This trial was registered with ClinicalTrials.gov, registration number: NCT01048866 , registration date: January 13, 2010.
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onset of action of a Lozenge containing flurbiprofen 8 75 mg a randomized double blind placebo controlled trial with a new method for measuring onset of analgesic activity
Pain, 2014Co-Authors: Bernard P. Schachtel, Adrian Shephard, Sue Aspley, K Sanner, Laurie Savino, Gary Smith, Timothy Shea, Jeanne Rezuke, E SchachtelAbstract:A new onset-of-action model was utilized to distinguish the pharmacologic activity of flurbiprofen 8.75mg delivered in a Lozenge from the demulcent effect of the Lozenge base. In a randomized, double-blind, placebo-controlled trial, patients with sore throat rated pain on a Sore Throat Pain Intensity Scale before taking one flurbiprofen or placebo Lozenge and at frequent (2-minute) intervals over the first hour after treatment. Further ratings of the Sore Throat Pain Intensity Scale and other patient-reported outcomes (difficulty swallowing, swollen throat, pain relief) were obtained at varying intervals over 6 hours. Onset of pharmacologic activity was defined as the median time of first perceived pain reduction if a patient reported clinically meaningful (at least moderate) relief. The conventional method of comparing mean treatment responses at each time point was also implemented. Demulcent action was detected at the first 2-minute assessment. By the new method, 102 flurbiprofen-treated patients were identified as first perceiving pain relief at 12 minutes, compared with >120 minutes by 102 patients using placebo (P<0.001). By the conventional method, mean percentage pain reduction for flurbiprofen 8.75 mg was first significantly differentiated from placebo at 26 minutes (P<0.05). Efficacy of flurbiprofen Lozenge was demonstrated for 3.5-4hours on the 4 patient-reported outcomes (all P<0.05 compared with placebo). There were no serious adverse events. This patient-centered onset-of-action model identifies the initiation of pain relief in patients who are definite drug responders, here demonstrating that a flurbiprofen 8.75-mg Lozenge provides early relief of sore throat.
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demonstration of dose response of flurbiprofen Lozenges with the sore throat pain model
Clinical Pharmacology & Therapeutics, 2002Co-Authors: Bernard P. Schachtel, Harvey D Homan, Iain A Gibb, Jenny ChristianAbstract:The dose response of flurbiprofen Lozenges (2.5, 5.0, and 12.5 mg) was evaluated in the treatment of sore throat. A refined version of the sore throat pain model showed that 12.5 mg flurbiprofen was significantly more effective than placebo at providing total pain relief and reducing throat soreness (p <.05). Flurbiprofen, 5.0 mg, was more effective than placebo for the reduction of throat soreness and the sensation of throat swelling (P <.05). The 2.5-mg flurbiprofen Lozenge was indistinguishable from placebo. For every milligram of increase in the dose of flurbiprofen, there was an approximately 0.3-unit increase in total pain relief (P <.05). Flurbiprofen Lozenges in all 3 dosages were well tolerated. Flurbiprofen Lozenges are effective for sore throat at a dose between 5.0 mg and 12.5 mg; the sore throat pain model is a sensitive assay for demonstration of the dose-response relationship of an analgesic agent.
Adrian Shephard - One of the best experts on this subject based on the ideXlab platform.
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bactericidal activity of hexylresorcinol Lozenges against oropharyngeal organisms associated with acute sore throat
BMC Research Notes, 2020Co-Authors: Derek Matthews, Oluwajoba Adegoke, Adrian ShephardAbstract:For the majority of people with acute sore throat, over-the-counter treatments represent the primary option for symptomatic relief. This study evaluated the in vitro bactericidal activity of Lozenges containing the antiseptic hexylresorcinol against five bacteria associated with acute sore throat: Staphylococcus aureus, Streptococcus pyogenes, Moraxella catarrhalis, Haemophilus influenzae and Fusobacterium necrophorum. Hexylresorcinol 2.4 mg Lozenges were dissolved into 5 mL of artificial saliva medium. Inoculum cultures were prepared in triplicate for each test organism to give an approximate population of 108 colony-forming units (cfu)/mL. Bactericidal activity was measured by log reduction in cfu. Greater than 3log10 reductions in cfu were observed at 1 min after dissolved hexylresorcinol Lozenges were added to S. aureus (log10 reduction cfu/mL ± standard deviation, 3.3 ± 0.2), M. catarrhalis (4.7 ± 0.4), H. influenzae (5.8 ± 0.4) and F. necrophorum (4.5 ± 0.2) and by 5 min for S. pyogenes (4.3 ± 0.4). Hexylresorcinol Lozenges achieved a > 99.9% reduction in cfu against all tested organisms within 5 min, which is consistent with the duration for a Lozenge to dissolve in the mouth. In conclusion, in vitro data indicate that hexylresorcinol Lozenges offer rapid bactericidal activity against organisms implicated in acute sore throat.
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efficacy of flurbiprofen 8 75 mg Lozenge in patients with a swollen and inflamed sore throat
Current Medical Research and Opinion, 2016Co-Authors: Sue Aspley, Adrian Shephard, E Schachtel, K Sanner, Laurie Savino, Bernard P. SchachtelAbstract:AbstractObjective: Sore throat is often over-treated with antibiotics, therefore there is a need for non-antibiotic treatments that provide effective relief. From the patient’s point of view, symptoms of pharyngeal inflammation such as a “swollen” and “inflamed” throat are often considered the most bothersome; so, a non-steroidal anti-inflammatory drug could be an appropriate treatment. We investigated the efficacy and safety of flurbiprofen 8.75 mg Lozenge in adults with a swollen and inflamed throat.Research design and methods: We enrolled adults with moderate-to-severe sore throat and evidence of tonsillo-pharyngitis into a randomized, double-blind study. Patients received flurbiprofen 8.75 mg or placebo Lozenges every 3–6 hours as needed (up to five Lozenges in 24 hours) and rated their symptoms (sore throat pain, difficulty swallowing and the sensation of a swollen throat) on standard linear scales regularly over 24 hours. The efficacy of flurbiprofen Lozenge was determined in patients reporting a sw...
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randomised double blind placebo controlled studies on flurbiprofen 8 75 mg Lozenges in patients with without group a or c streptococcal throat infection with an assessment of clinicians prediction of strep throat
International Journal of Clinical Practice, 2015Co-Authors: Adrian Shephard, G Smith, S Aspley, Bernard P. SchachtelAbstract:SummaryBackground Diagnosing group A streptococcus (Strep A) throat infection by clinical examination is difficult, and misdiagnosis may lead to inappropriate antibiotic use. Most patients with sore throat seek symptom relief rather than antibiotics, therefore, therapies that relieve symptoms should be recommended to patients. We report two clinical trials on the efficacy and safety of flurbiprofen 8.75 mg Lozenge in patients with and without streptococcal sore throat. Methods The studies enrolled adults with moderate-to-severe throat symptoms (sore throat pain, difficulty swallowing and swollen throat) and a diagnosis of pharyngitis. The practitioner assessed the likelihood of Strep A infection based on historical and clinical findings. Patients were randomised to flurbiprofen 8.75 mg or placebo Lozenges under double-blind conditions and reported the three throat symptoms at baseline and at regular intervals over 24 h. Results A total of 402 patients received study medication (n = 203 flurbiprofen, n = 199 placebo). Throat culture identified Strep A in 10.0% of patients and group C streptococcus (Strep C) in a further 14.0%. The practitioners' assessments correctly diagnosed Strep A in 11/40 cases (sensitivity 27.5%, and specificity 79.7%). A single flurbiprofen Lozenge provided significantly greater relief than placebo for all three throat symptoms, lasting 3–4 h for patients with and without Strep A/C. Multiple doses of flurbiprofen Lozenges over 24 h also led to symptom relief, although not statistically significant in the Strep A/C group. There were no serious adverse events. Conclusions The results highlight the challenge of identifying Strep A based on clinical features. With the growing problem of antibiotic resistance, non-antibiotic treatments should be considered. As demonstrated here, flurbiprofen 8.75 mg Lozenges are an effective therapeutic option, providing immediate and long-lasting symptom relief in patients with and without Strep A/C infection.
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utility of the sore throat pain model in a multiple dose assessment of the acute analgesic flurbiprofen a randomized controlled study
Trials, 2014Co-Authors: Bernard P. Schachtel, Adrian Shephard, Sue Aspley, Tim Shea, Gary Smith, E SchachtelAbstract:The sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials. The model used here was designed to study the multiple-dose safety and efficacy of Lozenges containing flurbiprofen at 8.75 mg. Adults (n = 198) with moderate or severe acute sore throat and findings of pharyngitis on a Tonsillo-Pharyngitis Assessment (TPA) were randomly assigned to use either flurbiprofen 8.75 mg Lozenges (n = 101) or matching placebo Lozenges (n = 97) under double-blind conditions. Patients sucked one Lozenge every three to six hours as needed, up to five Lozenges per day, and rated symptoms on 100-mm scales: the Sore Throat Pain Intensity Scale (STPIS), the Difficulty Swallowing Scale (DSS), and the Swollen Throat Scale (SwoTS). Reductions in pain (lasting for three hours) and in difficulty swallowing and throat swelling (for four hours) were observed after a single dose of the flurbiprofen 8.75 mg Lozenge (P <0.05 compared with placebo). After using multiple doses over 24 hours, flurbiprofen-treated patients experienced a 59% greater reduction in throat pain, 45% less difficulty swallowing, and 44% less throat swelling than placebo-treated patients (all P <0.01). There were no serious adverse events. Utilizing the sore throat pain model with multiple doses over 24 hours, flurbiprofen 8.75 mg Lozenges were shown to be an effective, well-tolerated treatment for sore throat pain. Other pharmacologic actions (reduced difficulty swallowing and reduced throat swelling) and overall patient satisfaction from the flurbiprofen Lozenges were also demonstrated in this multiple-dose implementation of the sore throat pain model. This trial was registered with ClinicalTrials.gov, registration number: NCT01048866 , registration date: January 13, 2010.
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onset of action of a Lozenge containing flurbiprofen 8 75 mg a randomized double blind placebo controlled trial with a new method for measuring onset of analgesic activity
Pain, 2014Co-Authors: Bernard P. Schachtel, Adrian Shephard, Sue Aspley, K Sanner, Laurie Savino, Gary Smith, Timothy Shea, Jeanne Rezuke, E SchachtelAbstract:A new onset-of-action model was utilized to distinguish the pharmacologic activity of flurbiprofen 8.75mg delivered in a Lozenge from the demulcent effect of the Lozenge base. In a randomized, double-blind, placebo-controlled trial, patients with sore throat rated pain on a Sore Throat Pain Intensity Scale before taking one flurbiprofen or placebo Lozenge and at frequent (2-minute) intervals over the first hour after treatment. Further ratings of the Sore Throat Pain Intensity Scale and other patient-reported outcomes (difficulty swallowing, swollen throat, pain relief) were obtained at varying intervals over 6 hours. Onset of pharmacologic activity was defined as the median time of first perceived pain reduction if a patient reported clinically meaningful (at least moderate) relief. The conventional method of comparing mean treatment responses at each time point was also implemented. Demulcent action was detected at the first 2-minute assessment. By the new method, 102 flurbiprofen-treated patients were identified as first perceiving pain relief at 12 minutes, compared with >120 minutes by 102 patients using placebo (P<0.001). By the conventional method, mean percentage pain reduction for flurbiprofen 8.75 mg was first significantly differentiated from placebo at 26 minutes (P<0.05). Efficacy of flurbiprofen Lozenge was demonstrated for 3.5-4hours on the 4 patient-reported outcomes (all P<0.05 compared with placebo). There were no serious adverse events. This patient-centered onset-of-action model identifies the initiation of pain relief in patients who are definite drug responders, here demonstrating that a flurbiprofen 8.75-mg Lozenge provides early relief of sore throat.
Darrell R Schroeder - One of the best experts on this subject based on the ideXlab platform.
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nicotine metabolite ratio is associated with Lozenge use but not quitting in smokeless tobacco users
Nicotine & Tobacco Research, 2016Co-Authors: Jon O Ebbert, Herbert H Severson, Brian G Danaher, Neal L Benowitz, Darrell R SchroederAbstract:Author(s): Ebbert, Jon O; Severson, Herbert H; Danaher, Brian G; Benowitz, Neal L; Schroeder, Darrell R | Abstract: IntroductionThe nicotine metabolite ratio (NMR) of 3'-hydroxycotinine to cotinine is a noninvasive marker of the rate of nicotine metabolism. Fast metabolism (ie, a high NMR) is associated with lower cigarette smoking abstinence rates using transdermal nicotine replacement. We evaluated whether the NMR can be used to predict self-reported nicotine Lozenge use and tobacco abstinence among smokeless tobacco users treated for tobacco dependence.MethodsThis was a secondary analysis of data from one arm of a large trial. Participants received quitting support materials and 4-mg nicotine Lozenges by mail plus three coaching phone calls. Saliva kits were mailed for collection of saliva samples, which were analyzed for cotinine and 3'-hydroxycotinine. Self-reported tobacco and Lozenge use were assessed at 3 months. Analyses were performed using Spearman rank correlation and logistic regression.ResultsOf the 160 saliva collection kits mailed, 152 were returned. The NMR was not significantly correlated with the baseline amount of smokeless tobacco used, the number of years of tobacco use, or the level of tobacco dependence as measured by the Severson Smokeless Tobacco Dependency Scale. The NMR was positively correlated with Lozenge use (r = 0.21, P = .015), but it did not predict self-reported 7-day point prevalence abstinence at 3 months.ConclusionsFast metabolizers may need to self-administer more nicotine replacement in the form of nicotine Lozenges to achieve the same clinical response achieved by slower metabolizers using fewer Lozenges.
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comparative effectiveness of the nicotine Lozenge and tobacco free snuff for smokeless tobacco reduction
Addictive Behaviors, 2013Co-Authors: Jon O Ebbert, Herbert H Severson, Ivana T Croghan, Brian G Danaher, Darrell R SchroederAbstract:Abstract Long-term smokeless tobacco (ST) use is associated with cardiovascular disease and cancer, but not all ST users want to quit. Previous studies have evaluated the effectiveness of nicotine Lozenges and tobacco-free snuff for reducing ST use among ST users not ready to quit, but no comparative effectiveness trials of these two products have been conducted. We conducted a multicenter, randomized clinical pilot study evaluating the comparative effectiveness of the 4-mg nicotine Lozenge and tobacco-free snuff for reducing ST use and increasing tobacco abstinence among ST users with no intention of quitting in the next 30 days. Participants received 8 weeks of treatment and behavioral counseling on tobacco reduction strategies with follow-up to 26 weeks. We randomized 81 participants (40 nicotine Lozenges, 41 tobacco-free snuff). No significant differences in reduction were observed between the two groups at weeks 8, 12, and 26. No significant differences were observed between groups in nicotine withdrawal or tobacco craving. However, both groups significantly reduced ( p p = .615). The 4-mg nicotine Lozenge and the tobacco-free snuff both appear to be effective and comparable for reducing ST use among ST users not ready to quit in the next 30 days.
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a randomized clinical trial of nicotine Lozenge for smokeless tobacco use
Nicotine & Tobacco Research, 2009Co-Authors: Jon O Ebbert, Herbert H Severson, Ivana T Croghan, Brian G Danaher, Darrell R SchroederAbstract:Introduction: Smokeless tobacco (ST) use is associated with adverse health consequences, and effective treatments are needed. Pilot data suggest that 4-mg nicotine Lozenge decreases tobacco craving and nicotine withdrawal symptoms among ST users. Methods: We conducted a randomized, placebo-controlled multicenter clinical trial to evaluate the effi cacy of 12 weeks of 4-mg nicotine Lozenge for ST use. Results: We randomized 270 participants (136 active Lozenge, 134 placebo). No signifi cant differences were observed between the groups in biochemically confi rmed all tobacco abstinence rates at Week 12 (36% Lozenge vs. 27.6% placebo; odds ratio [ OR ] 1.5, 95% CI 0.7 – 2.1; p = .138). However, the 4-mg nicotine Lozenge increased self-reported all tobacco abstinence (44.1% vs. 29.1%; OR 1.9, 95% CI 1.2 – 3.2; p = .011) and selfreported ST abstinence (50.7% vs. 34.3%; OR 2.0, 95% CI 1.2 – 3.2; p = .013) compared with placebo at the end of treatment (Week 12). Following target quit date (TQD), nicotine withdrawal symptoms decreased signifi cantly with time (time effect = − .022 per day, SE = .003; p < .001) and was signifi cantly lower for the active Lozenge (treatment effect = − .213, SE = .071; p = .003). Tobacco craving also decreased signifi cantly following TQD (time effect = − .071, SE = .006; p < .001) and was lower for the active nicotine Lozenge (treatment effect = − .452, SE = .164; p = .006). Discussion: The 4-mg nicotine Lozenge increased self-reported but not biochemically confi rmed tobacco abstinence rates at 3 months. The use of the 4-mg nicotine Lozenge is associated with decreased nicotine withdrawal symptoms and tobacco craving.
Jenny Christian - One of the best experts on this subject based on the ideXlab platform.
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demonstration of dose response of flurbiprofen Lozenges with the sore throat pain model
Clinical Pharmacology & Therapeutics, 2002Co-Authors: Bernard P. Schachtel, Harvey D Homan, Iain A Gibb, Jenny ChristianAbstract:The dose response of flurbiprofen Lozenges (2.5, 5.0, and 12.5 mg) was evaluated in the treatment of sore throat. A refined version of the sore throat pain model showed that 12.5 mg flurbiprofen was significantly more effective than placebo at providing total pain relief and reducing throat soreness (p <.05). Flurbiprofen, 5.0 mg, was more effective than placebo for the reduction of throat soreness and the sensation of throat swelling (P <.05). The 2.5-mg flurbiprofen Lozenge was indistinguishable from placebo. For every milligram of increase in the dose of flurbiprofen, there was an approximately 0.3-unit increase in total pain relief (P <.05). Flurbiprofen Lozenges in all 3 dosages were well tolerated. Flurbiprofen Lozenges are effective for sore throat at a dose between 5.0 mg and 12.5 mg; the sore throat pain model is a sensitive assay for demonstration of the dose-response relationship of an analgesic agent.
E Schachtel - One of the best experts on this subject based on the ideXlab platform.
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efficacy of flurbiprofen 8 75 mg Lozenge in patients with a swollen and inflamed sore throat
Current Medical Research and Opinion, 2016Co-Authors: Sue Aspley, Adrian Shephard, E Schachtel, K Sanner, Laurie Savino, Bernard P. SchachtelAbstract:AbstractObjective: Sore throat is often over-treated with antibiotics, therefore there is a need for non-antibiotic treatments that provide effective relief. From the patient’s point of view, symptoms of pharyngeal inflammation such as a “swollen” and “inflamed” throat are often considered the most bothersome; so, a non-steroidal anti-inflammatory drug could be an appropriate treatment. We investigated the efficacy and safety of flurbiprofen 8.75 mg Lozenge in adults with a swollen and inflamed throat.Research design and methods: We enrolled adults with moderate-to-severe sore throat and evidence of tonsillo-pharyngitis into a randomized, double-blind study. Patients received flurbiprofen 8.75 mg or placebo Lozenges every 3–6 hours as needed (up to five Lozenges in 24 hours) and rated their symptoms (sore throat pain, difficulty swallowing and the sensation of a swollen throat) on standard linear scales regularly over 24 hours. The efficacy of flurbiprofen Lozenge was determined in patients reporting a sw...
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utility of the sore throat pain model in a multiple dose assessment of the acute analgesic flurbiprofen a randomized controlled study
Trials, 2014Co-Authors: Bernard P. Schachtel, Adrian Shephard, Sue Aspley, Tim Shea, Gary Smith, E SchachtelAbstract:The sore throat pain model has been conducted by different clinical investigators to demonstrate the efficacy of acute analgesic drugs in single-dose randomized clinical trials. The model used here was designed to study the multiple-dose safety and efficacy of Lozenges containing flurbiprofen at 8.75 mg. Adults (n = 198) with moderate or severe acute sore throat and findings of pharyngitis on a Tonsillo-Pharyngitis Assessment (TPA) were randomly assigned to use either flurbiprofen 8.75 mg Lozenges (n = 101) or matching placebo Lozenges (n = 97) under double-blind conditions. Patients sucked one Lozenge every three to six hours as needed, up to five Lozenges per day, and rated symptoms on 100-mm scales: the Sore Throat Pain Intensity Scale (STPIS), the Difficulty Swallowing Scale (DSS), and the Swollen Throat Scale (SwoTS). Reductions in pain (lasting for three hours) and in difficulty swallowing and throat swelling (for four hours) were observed after a single dose of the flurbiprofen 8.75 mg Lozenge (P <0.05 compared with placebo). After using multiple doses over 24 hours, flurbiprofen-treated patients experienced a 59% greater reduction in throat pain, 45% less difficulty swallowing, and 44% less throat swelling than placebo-treated patients (all P <0.01). There were no serious adverse events. Utilizing the sore throat pain model with multiple doses over 24 hours, flurbiprofen 8.75 mg Lozenges were shown to be an effective, well-tolerated treatment for sore throat pain. Other pharmacologic actions (reduced difficulty swallowing and reduced throat swelling) and overall patient satisfaction from the flurbiprofen Lozenges were also demonstrated in this multiple-dose implementation of the sore throat pain model. This trial was registered with ClinicalTrials.gov, registration number: NCT01048866 , registration date: January 13, 2010.
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onset of action of a Lozenge containing flurbiprofen 8 75 mg a randomized double blind placebo controlled trial with a new method for measuring onset of analgesic activity
Pain, 2014Co-Authors: Bernard P. Schachtel, Adrian Shephard, Sue Aspley, K Sanner, Laurie Savino, Gary Smith, Timothy Shea, Jeanne Rezuke, E SchachtelAbstract:A new onset-of-action model was utilized to distinguish the pharmacologic activity of flurbiprofen 8.75mg delivered in a Lozenge from the demulcent effect of the Lozenge base. In a randomized, double-blind, placebo-controlled trial, patients with sore throat rated pain on a Sore Throat Pain Intensity Scale before taking one flurbiprofen or placebo Lozenge and at frequent (2-minute) intervals over the first hour after treatment. Further ratings of the Sore Throat Pain Intensity Scale and other patient-reported outcomes (difficulty swallowing, swollen throat, pain relief) were obtained at varying intervals over 6 hours. Onset of pharmacologic activity was defined as the median time of first perceived pain reduction if a patient reported clinically meaningful (at least moderate) relief. The conventional method of comparing mean treatment responses at each time point was also implemented. Demulcent action was detected at the first 2-minute assessment. By the new method, 102 flurbiprofen-treated patients were identified as first perceiving pain relief at 12 minutes, compared with >120 minutes by 102 patients using placebo (P<0.001). By the conventional method, mean percentage pain reduction for flurbiprofen 8.75 mg was first significantly differentiated from placebo at 26 minutes (P<0.05). Efficacy of flurbiprofen Lozenge was demonstrated for 3.5-4hours on the 4 patient-reported outcomes (all P<0.05 compared with placebo). There were no serious adverse events. This patient-centered onset-of-action model identifies the initiation of pain relief in patients who are definite drug responders, here demonstrating that a flurbiprofen 8.75-mg Lozenge provides early relief of sore throat.
