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Joanne Wilkinson - One of the best experts on this subject based on the ideXlab platform.

  • Randomized clinical trial: a double-blind, placebo-controlled study to assess the clinical efficacy and safety of alginate-antacid (Gaviscon Double Action) chewable tablets in patients with gastro-oesophageal reflux disease.
    European journal of gastroenterology & hepatology, 2019
    Co-Authors: Joanne Wilkinson, Alan Wade, S. Jane Thomas, Bartosz Jenner, Victoria Hodgkinson, Cathal Coyle
    Abstract:

    BackgroundThe alginate–antacid Gaviscon Double Action (Gaviscon DA) has a combined acid-neutralizing and reflux-suppressing action. Response to treatment in a symptomatic gastro-oesophageal reflux disease (GERD) population has not yet been tested in a large-scale clinical study.AimThe aim of this st

  • Randomised clinical trial: addition of alginate-antacid (Gaviscon Double Action) to proton pump inhibitor therapy in patients with breakthrough symptoms.
    Alimentary pharmacology & therapeutics, 2017
    Co-Authors: C. Coyle, Joanne Wilkinson, G Crawford, S. J. Thomas, Peter Bytzer
    Abstract:

    SummaryBackground Symptomatic breakthrough in proton pump inhibitor (PPI)-treated gastro-oesophageal reflux disease (GERD) patients is a common problem with a range of underlying causes. The nonsystemic, raft-forming action of alginates may help resolve symptoms. Aim To assess alginate-antacid (Gaviscon Double Action, RB, Slough, UK) as add-on therapy to once-daily PPI for suppression of breakthrough reflux symptoms. Methods In two randomised, double-blind studies (exploratory, n=52; confirmatory, n=262), patients taking standard-dose PPI who had breakthrough symptoms, assessed by Heartburn Reflux Dyspepsia Questionnaire (HRDQ), were randomised to add-on Gaviscon or placebo (20 mL after meals and bedtime). The exploratory study endpoint was change in HRDQ score during treatment vs run-in. The confirmatory study endpoint was “response” defined as ≥3 days reduction in the number of “bad” days (HRDQ [heartburn/regurgitation] >0.70) during treatment vs run-in. Results In the exploratory study, significantly greater reductions in HRDQ scores (heartburn/regurgitation) were observed in the Gaviscon vs placebo (least squares mean difference [95% CI] −2.10 [−3.71 to −0.48]; P=.012). Post hoc “responder” analysis of the exploratory study also revealed significantly more Gaviscon patients (75%) achieved ≥3 days reduction in “bad” days vs placebo patients (36%), P=.005. In the confirmatory study, symptomatic improvement was observed with add-on Gaviscon (51%) but there was no significant difference in response vs placebo (48%) (OR (95% CI) 1.15 (0.69-1.91), P=.5939). Conclusions Adding Gaviscon to PPI reduced breakthrough GERD symptoms but a nearly equal response was observed for placebo. Response to intervention may vary according to whether symptoms are functional in origin.

  • randomised clinical trial alginate Gaviscon advance vs placebo as add on therapy in reflux patients with inadequate response to a once daily proton pump inhibitor
    Alimentary Pharmacology & Therapeutics, 2016
    Co-Authors: Christina Reimer, Joanne Wilkinson, Anders Lødrup, Gary B. Smith, Peter Bytzer
    Abstract:

    SummaryBackground Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression. Aim To assess the efficacy of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. Methods This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using the Heartburn Reflux Dyspepsia Questionnaire (HRDQ). Based on symptom score during run-in, eligible patients were randomised to Gaviscon Advance 10 mL four times a day or placebo in addition to a once daily PPI. The primary endpoint was change in HRDQ score post-treatment compared to baseline. Results One hundred and thirty-six patients were randomised. Change in HRDQ reflux score was significantly greater for Gaviscon Advance (mean: −5.0, s.d.: 4.7) than for placebo (mean: −3.5, s.d.: 5.5) with an LS mean difference of 1.6 [95% CI −3.1 to −0.1], P = 0.03. A decrease in the mean (s.d.) number of nights with symptoms was observed from 3.6 (2.8) to 3.0 (3.0) in the placebo group and from 3.9 (2.8) to 2.2 (2.7) for the Gaviscon Advance group. This reduction was significantly greater in the Gaviscon Advance group than in the placebo group [LS mean difference = −0.9, 95% CI (−1.6 to −0.2), P < 0.01]. Conclusion In patients with residual reflux symptoms despite PPI treatment, adding an alginate offers additional decrease in the burden of reflux symptoms (EudraCT/IND Number: 2011-005486-21).

  • Randomised clinical trial: Alginate (Gaviscon Advance) vs. placebo as add-on therapy in reflux patients with inadequate response to a once daily proton pump inhibitor
    Alimentary pharmacology & therapeutics, 2016
    Co-Authors: Christina Reimer, Joanne Wilkinson, Anders Lødrup, Gary B. Smith, Peter Bytzer
    Abstract:

    SummaryBackground Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression. Aim To assess the efficacy of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. Methods This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using the Heartburn Reflux Dyspepsia Questionnaire (HRDQ). Based on symptom score during run-in, eligible patients were randomised to Gaviscon Advance 10 mL four times a day or placebo in addition to a once daily PPI. The primary endpoint was change in HRDQ score post-treatment compared to baseline. Results One hundred and thirty-six patients were randomised. Change in HRDQ reflux score was significantly greater for Gaviscon Advance (mean: −5.0, s.d.: 4.7) than for placebo (mean: −3.5, s.d.: 5.5) with an LS mean difference of 1.6 [95% CI −3.1 to −0.1], P = 0.03. A decrease in the mean (s.d.) number of nights with symptoms was observed from 3.6 (2.8) to 3.0 (3.0) in the placebo group and from 3.9 (2.8) to 2.2 (2.7) for the Gaviscon Advance group. This reduction was significantly greater in the Gaviscon Advance group than in the placebo group [LS mean difference = −0.9, 95% CI (−1.6 to −0.2), P 

  • randomised clinical trial the clinical efficacy and safety of an alginate antacid Gaviscon double action versus placebo for decreasing upper gastrointestinal symptoms in symptomatic gastroesophageal reflux disease gerd in china
    Alimentary Pharmacology & Therapeutics, 2015
    Co-Authors: J. Sun, C. Yang, P. Zheng, Joanne Wilkinson, H Zhao, Y.-z. Yuan
    Abstract:

    Summary Background There is a paucity of large-scale studies evaluating the clinical benefit of the Gaviscon Double Action (DA) alginate-antacid formulation for treating gastroesophageal reflux disease (GERD) symptoms. Aim Randomised double-blind placebo-controlled parallel-group study to evaluate efficacy and safety of Gaviscon DA in reducing heartburn, regurgitation and dyspepsia symptoms in individuals with mild-to-moderate GERD in China. Methods Participants with symptomatic GERD (n = 1107) were randomised to receive Gaviscon DA or placebo (two tablets four times daily) for seven consecutive days. The primary endpoint compared the change in Reflux Disease Questionnaire (RDQ) score for the GERD (heartburn + regurgitation) dimension between Gaviscon DA and placebo. Secondary endpoints compared the change in RDQ scores for individual heartburn, regurgitation and dyspepsia dimensions, overall treatment evaluation (OTE) scores and incidence of adverse events (AEs). Results Mean RDQ GERD scores: 2.51 for Gaviscon DA and 2.50 for placebo at baseline; 1.25 for Gaviscon DA and 1.46 for placebo post treatment. Gaviscon DA was statistically superior to placebo in reducing GERD and dyspepsia RDQ scores [least-squares mean (LSM) difference: GERD −0.21, P < 0.0001; dyspepsia −0.18, P = 0.0004], despite a substantial placebo response. The Gaviscon DA group reported more favourable overall treatment responses than the placebo group across all OTE categories (P < 0.0001). Superior relief of GERD symptoms was observed both in those with non-erosive and those with erosive reflux disease (LSM difference −0.14 [P = 0.038] and −0.29 [P < 0.0001] respectively). Incidence of AEs was similar in both groups. Conclusion Gaviscon DA tablets provide effective and safe reduction in acid reflux and dyspepsia symptoms in Chinese individuals with mild-to-moderate GERD. ClinicalTrials.gov: NCT01869491

Peter W. Dettmar - One of the best experts on this subject based on the ideXlab platform.

  • A comparative study on the raft chemical properties of various alginate antacid raft-forming products
    Drug Development and Industrial Pharmacy, 2017
    Co-Authors: Peter W. Dettmar, Diana Gil-gonzalez, Jeanine Fisher, Lucy Flint, Daniel Rainforth, Antonio Moreno-herrera, Mark Potts
    Abstract:

    AbstractObjective: Research to measure the chemical characterization of alginate rafts for good raft performance and ascertain how formulation can affect chemical parameters.Significance: A selection of alginate formulations was investigated all claiming to be proficient raft formers with significance between products established and ranked.Methods: Procedures were selected which demonstrated the chemical characterization allowing rafts to effectively impede the reflux into the esophagus or in severe cases to be refluxed preferentially into the esophagus and exert a demulcent effect, with focus of current research on methods which complement previous studies centered on physical properties. The alginate content was analyzed by a newly developed HPLC method. Methods were used to determine the neutralization profile and the acid neutralization within the raft determined along with how raft structure affects neutralization.Results: Alginate content of Gaviscon Double Action (GDA) within the raft was signific...

  • 403 PUBLICATIONS 14,610 CITATIONS SEE PROFILE
    2016
    Co-Authors: Peter W. Dettmar, Luca Marciani, Sarah L. Little, Janice Snee, Nicholas S. Coleman, Damian J. Tyler, Penny A. Gowland, Robin Spiller, John Sykes
    Abstract:

    Echo-planar magnetic resonance imaging of Gaviscon alginate rafts in-viv

  • post prandial reflux suppression by a raft forming alginate Gaviscon advance compared to a simple antacid documented by magnetic resonance imaging and ph impedance monitoring mechanistic assessment in healthy volunteers and randomised controlled doub
    Alimentary Pharmacology & Therapeutics, 2013
    Co-Authors: Randy F Sweis, Peter W. Dettmar, Elad Kaufman, A Anggiansah, Terry Wong, Michael Fried, Werner Schwizer, R K Avvari, A Pal, Mark Fox
    Abstract:

    SummaryBackground Alginates form a raft above the gastric contents, which may suppress gastro-oesophageal reflux; however, inconsistent effects have been reported in mechanistic and clinical studies. Aims To visualise reflux suppression by an alginate–antacid [Gaviscon Advance (GA), Reckitt Benckiser, UK] compared with a nonraft-forming antacid using magnetic resonance imaging (MRI), and to determine the feasibility of pH-impedance monitoring for assessment of reflux suppression by alginates. Methods Two studies were performed: (i) GA and antacid (Alucol, Wander Ltd, Switzerland) were visualised in the stomach after ingestion in 12 healthy volunteers over 30 min after a meal by MRI, with reflux events documented by manometry. (ii) A randomised controlled, double-blind cross-over trial of post-prandial reflux suppression documented by pH-impedance in 20 patients randomised to GA or antacid (Milk of Magnesia; Boots, UK) after two meals taken 24 h apart. Results MRI visualized a “mass” of GA form at the oesophago-gastric junction (OGJ); simple antacid sank to the distal stomach. The number of post-prandial common cavity reflux events was less with GA than antacid [median 2 (0–5) vs. 5 (1–11); P < 0.035]. Distal reflux events and acid exposure measured by pH-impedance were similar after GA and antacid. There was a trend to reduced proximal reflux events with GA compared with antacid [10.5 (8.9) vs. 13.9 (8.3); P = 0.070]. Conclusions Gaviscon Advance forms a ‘mass’ close to the OGJ and significantly suppresses reflux compared with a nonraft-forming antacid. Standard pH-impedance monitoring is suitable for clinical studies of GA in gastro-oesophageal reflux disease patients where proximal reflux is the primary outcome.

  • Evaluation of an Innovative Over-the-Counter Treatment for Symptoms of Reflux Disease: Quick-Dissolving Alginate Granules
    ISRN pharmaceutics, 2012
    Co-Authors: Vicki Strugala, Peter W. Dettmar, Edward C. M. Thomas
    Abstract:

    Traditional antacids and alginate-based reflux suppressants are OTC products commonly used to treat reflux symptoms. There has been a lack of innovation of new formulations in this therapy area despite consumers finding established products unpalatable. Here we evaluate a novel product formulation which takes the form of quick-dissolving alginate granules in single-dose sachets (Gaviscon Direct Powder (GDP)). Market research and taste evaluation confirmed that reflux sufferers considered GDP to have good flavour and taste, no chalky aftertaste and dissolved rapidly in the mouth with 68% noting so within 10 seconds. GDP was considered convenient and easy to use. The consumer-driven product development was also shown to form a strong alginate raft in standardised in vitro conditions that met the specifications of the BP monograph (raft strength > 7.5 g). Gastric retention of GDP and a test meal was investigated in healthy volunteers using gamma scintigraphy in comparison to Liquid Gaviscon. Both products formed an alginate raft in the stomach above the test meal and emptied after the meal. The gastric retention of the GDP product was found to be noninferior to Liquid Gaviscon. In conclusion, the innovative GDP product formed an effective raft and was well liked by consumers.

  • A Randomized, Controlled, Crossover Trial to Investigate Times to Onset of the Perception of Soothing and Cooling by Over-The-Counter Heartburn Treatments
    The Journal of international medical research, 2010
    Co-Authors: V Strugala, Peter W. Dettmar, K Sarratt, J. Sykes, Phillip Berry, Edward C. M. Thomas
    Abstract:

    This was a randomized, controlled, four-way crossover study in 45 subjects with a tendency to suffer from moderate heartburn following some meals. The study was designed to assess the time to onset of the perceived soothing and cooling effects of the alginate raft-forming products, Gaviscon Liquid (peppermint), Gaviscon Double Action Liquid (peppermint) and Gaviscon Powder Formulation (fresh tropical), compared with a non-active sublingual control. All three Gaviscon products provided significantly faster soothing and cooling effects compared with the control. Based on the upper 95% confidence limits for the median, time to onset of soothing was perceived within 3.15 min, 3.08 min and 4.05 min for Gaviscon Liquid, Double Action Liquid and Powder Formulation, respectively. Similarly, time to onset of cooling was perceived within 1.95 min, 1.23 min and 11.22 min for Gaviscon Liquid, Double Action Liquid and Powder Formulation, respectively. The results show that Gaviscon Liquid and Gaviscon Double Action so...

Peter Bytzer - One of the best experts on this subject based on the ideXlab platform.

  • Randomised clinical trial: addition of alginate-antacid (Gaviscon Double Action) to proton pump inhibitor therapy in patients with breakthrough symptoms.
    Alimentary pharmacology & therapeutics, 2017
    Co-Authors: C. Coyle, Joanne Wilkinson, G Crawford, S. J. Thomas, Peter Bytzer
    Abstract:

    SummaryBackground Symptomatic breakthrough in proton pump inhibitor (PPI)-treated gastro-oesophageal reflux disease (GERD) patients is a common problem with a range of underlying causes. The nonsystemic, raft-forming action of alginates may help resolve symptoms. Aim To assess alginate-antacid (Gaviscon Double Action, RB, Slough, UK) as add-on therapy to once-daily PPI for suppression of breakthrough reflux symptoms. Methods In two randomised, double-blind studies (exploratory, n=52; confirmatory, n=262), patients taking standard-dose PPI who had breakthrough symptoms, assessed by Heartburn Reflux Dyspepsia Questionnaire (HRDQ), were randomised to add-on Gaviscon or placebo (20 mL after meals and bedtime). The exploratory study endpoint was change in HRDQ score during treatment vs run-in. The confirmatory study endpoint was “response” defined as ≥3 days reduction in the number of “bad” days (HRDQ [heartburn/regurgitation] >0.70) during treatment vs run-in. Results In the exploratory study, significantly greater reductions in HRDQ scores (heartburn/regurgitation) were observed in the Gaviscon vs placebo (least squares mean difference [95% CI] −2.10 [−3.71 to −0.48]; P=.012). Post hoc “responder” analysis of the exploratory study also revealed significantly more Gaviscon patients (75%) achieved ≥3 days reduction in “bad” days vs placebo patients (36%), P=.005. In the confirmatory study, symptomatic improvement was observed with add-on Gaviscon (51%) but there was no significant difference in response vs placebo (48%) (OR (95% CI) 1.15 (0.69-1.91), P=.5939). Conclusions Adding Gaviscon to PPI reduced breakthrough GERD symptoms but a nearly equal response was observed for placebo. Response to intervention may vary according to whether symptoms are functional in origin.

  • randomised clinical trial alginate Gaviscon advance vs placebo as add on therapy in reflux patients with inadequate response to a once daily proton pump inhibitor
    Alimentary Pharmacology & Therapeutics, 2016
    Co-Authors: Christina Reimer, Joanne Wilkinson, Anders Lødrup, Gary B. Smith, Peter Bytzer
    Abstract:

    SummaryBackground Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression. Aim To assess the efficacy of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. Methods This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using the Heartburn Reflux Dyspepsia Questionnaire (HRDQ). Based on symptom score during run-in, eligible patients were randomised to Gaviscon Advance 10 mL four times a day or placebo in addition to a once daily PPI. The primary endpoint was change in HRDQ score post-treatment compared to baseline. Results One hundred and thirty-six patients were randomised. Change in HRDQ reflux score was significantly greater for Gaviscon Advance (mean: −5.0, s.d.: 4.7) than for placebo (mean: −3.5, s.d.: 5.5) with an LS mean difference of 1.6 [95% CI −3.1 to −0.1], P = 0.03. A decrease in the mean (s.d.) number of nights with symptoms was observed from 3.6 (2.8) to 3.0 (3.0) in the placebo group and from 3.9 (2.8) to 2.2 (2.7) for the Gaviscon Advance group. This reduction was significantly greater in the Gaviscon Advance group than in the placebo group [LS mean difference = −0.9, 95% CI (−1.6 to −0.2), P < 0.01]. Conclusion In patients with residual reflux symptoms despite PPI treatment, adding an alginate offers additional decrease in the burden of reflux symptoms (EudraCT/IND Number: 2011-005486-21).

  • Randomised clinical trial: Alginate (Gaviscon Advance) vs. placebo as add-on therapy in reflux patients with inadequate response to a once daily proton pump inhibitor
    Alimentary pharmacology & therapeutics, 2016
    Co-Authors: Christina Reimer, Joanne Wilkinson, Anders Lødrup, Gary B. Smith, Peter Bytzer
    Abstract:

    SummaryBackground Many reflux patients remain symptomatic on a standard dose of proton pump inhibitor (PPI). Alginates decrease the number of reflux events by forming a raft on top of the stomach content and thus offer a supplemental mechanism of action to acid suppression. Aim To assess the efficacy of an alginate (Gaviscon Advance, Reckitt Benckiser, Slough, UK) on reflux symptoms in patients with persistent symptoms despite once daily PPI. Methods This was a multicentre, randomised, placebo-controlled, 7-day double-blind trial preceded by a 7-day run-in period. Reflux symptoms were assessed using the Heartburn Reflux Dyspepsia Questionnaire (HRDQ). Based on symptom score during run-in, eligible patients were randomised to Gaviscon Advance 10 mL four times a day or placebo in addition to a once daily PPI. The primary endpoint was change in HRDQ score post-treatment compared to baseline. Results One hundred and thirty-six patients were randomised. Change in HRDQ reflux score was significantly greater for Gaviscon Advance (mean: −5.0, s.d.: 4.7) than for placebo (mean: −3.5, s.d.: 5.5) with an LS mean difference of 1.6 [95% CI −3.1 to −0.1], P = 0.03. A decrease in the mean (s.d.) number of nights with symptoms was observed from 3.6 (2.8) to 3.0 (3.0) in the placebo group and from 3.9 (2.8) to 2.2 (2.7) for the Gaviscon Advance group. This reduction was significantly greater in the Gaviscon Advance group than in the placebo group [LS mean difference = −0.9, 95% CI (−1.6 to −0.2), P 

Cathal Coyle - One of the best experts on this subject based on the ideXlab platform.

Yeong Yeh Lee - One of the best experts on this subject based on the ideXlab platform.

  • randomised clinical trial the effectiveness of Gaviscon advance vs non alginate antacid in suppression of acid pocket and post prandial reflux in obese individuals after late night supper
    Alimentary Pharmacology & Therapeutics, 2020
    Co-Authors: Mohd Adli Deraman, Muhammad Ilham Abdul Hafidz, Rona Marie Lawenko, Zheng Feei, Mung Seong Wong, Cathal Coyle, Yeong Yeh Lee
    Abstract:

    BACKGROUND Late-night supper increases the risk of postprandial reflux from the acid pocket especially in obesity. An alginate-based, raft-forming medication may be useful for obese patients with GERD. AIMS To compare the efficacy of Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid in post-supper suppression of the acid pocket and post-prandial reflux among obese participants. METHODS Participants underwent 48 h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively, and were randomised to single post-supper (10 pm) dose of either Gaviscon Advance or a non-alginate antacid on the second night. Primary outcomes were suppression of median pH of acid pocket and lower oesophagus, measured every 10-minutes post-supper for 1 h. Secondary outcomes were suppression of % time pH < 4 at lower oesophagus and improvement in frequency and visual analogue score (VAS) of regurgitation. RESULTS Of the 81 screened participants, 55 were excluded and 26 (mean age 33.5 years, males 77.8% and BMI 32.8 kg/m2 ) were randomised to Gaviscon Advance (n = 13) or antacid (n = 13). Median pH of the acid pocket but not the lower oesophagus was suppressed with Gaviscon Advance vs antacid (all P < 0.04) Gaviscon Advance but not antacid significantly reduced in % time pH < 4, symptom frequency and VAS on day 2 vs day 1 (all P < 0.05). CONCLUSIONS Among obese individuals, Gaviscon Advance was superior to a non-alginate antacid in post-supper suppression of the acid pocket. (Clinical trial registration unique identifier: NCT03516188).

  • Randomised clinical trial: the effectiveness of Gaviscon Advance vs non-alginate antacid in suppression of acid pocket and post-prandial reflux in obese individuals after late-night supper.
    Alimentary pharmacology & therapeutics, 2020
    Co-Authors: Mohd Adli Deraman, Muhammad Ilham Abdul Hafidz, Rona Marie Lawenko, Zheng Feei, Mung Seong Wong, Cathal Coyle, Yeong Yeh Lee
    Abstract:

    BACKGROUND Late-night supper increases the risk of postprandial reflux from the acid pocket especially in obesity. An alginate-based, raft-forming medication may be useful for obese patients with GERD. AIMS To compare the efficacy of Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid in post-supper suppression of the acid pocket and post-prandial reflux among obese participants. METHODS Participants underwent 48 h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively, and were randomised to single post-supper (10 pm) dose of either Gaviscon Advance or a non-alginate antacid on the second night. Primary outcomes were suppression of median pH of acid pocket and lower oesophagus, measured every 10-minutes post-supper for 1 h. Secondary outcomes were suppression of % time pH 

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