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Generated: December 17, 2018

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CLINICAL TRIALS PROFILE FOR GAVISCON

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Clinical Trials for Gaviscon

Trial ID Title Status Sponsor Phase Summary
NCT01373970 The Clinical Significance of Acid Rebound in Functional Dyspepsia Terminated University Hospital Koge Phase 4 Proton pump inhibitors (PPI) have been shown to cause acid reflux related symptoms at withdrawal in healthy volunteers, a phenomenon known as Rebound Acid Hyper Secretion. Whether this also applies for patients with dyspeptic symptoms but without true reflux disease (functional dyspepsia) treated with PPI is unknown. If this is the case, it could lead to an unfortunate long term use of PPI, since the acid rebound renders withdrawal too difficult. This is a single centre, randomized, double-blinded, placebo-controlled cross over study. Study period is 12 weeks per study subject. Study subjects are referred to the study from General Practitioner (GP) and the gastroenterology department or endoscopy clinic of the investigational centre. The study population consists of patients who seek their GP because of dyspepsia without alert signs, and whom the GP may consider starting on PPI. Out patients referred to the gastroenterology department or endoscopy clinic of the investigational centre because of dyspepsia without specific exclusion criteria are also invited to participate. Baseline interview, upper endoscopy and pH monitoring are performed one week before inclusion to exclude patients with GERD. Helicobacter Pylori (Hp.) status is assessed by Helicobacter Urease Test (HUT). Hp. positive subjects without ulcus are not excluded. Patients with a positive pH monitoring will not be included in the analysis regarding the primary endpoint (Development of GERD) but will be included in the analysis regarding one of the secondary endpoints (Effect of PPI on Functional Dyspepsia). Study subjects are randomized to either pantoprazol followed by cross over to placebo or to placebo. Escape medication in the form of Gaviscon can be used on demand. Internet based questionnaires are answered weekly. Questionnaires consist of the Gastrointestinal Symptom rating Scale (GSRS) in combination with items assessing postprandial fullness and items assessing the Montreal Criteria for Gastro Esophageal Reflux Disease (GERD). Compliance to protocol is assessed at hospital visits every fourth week. At the end of study endoscopy and pH monitoring are repeated.
NCT02783378 48 Hours Esophagal pH-monitoring With and Without Gaviscon Not yet recruiting Universitair Ziekenhuis Brussel N/A At a esophagal pH-monitoring will the classic 24-hour measurement be extended to 48 hours. During the first 24 hours are the measurements without medication. After 24 hours the treatment will be started with Gaviscon and will the next 24 hours the measurements under the medication happen. Normally is the medication required after the measurements. With this study the investigators will have multiple measurement points to compare.
NCT03065816 Scintigraphy Study to Compare the Antireflux Activity of the Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects Completed Sanofi Phase 1 Primary Objective: Pharmacodynamics: assessment and comparison by gamma scintigraphy of the gastric retention of alginate rafts (raft performance) of Z0063 to the effect of Gaviscon Double Action Tablets, in healthy adult subjects. Secondary Objective: Safety: assessment of the clinical safety of Z0063 versus Gaviscon Double Action tablets, in healthy adult subjects.
NCT03069963 PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects Recruiting Sanofi Phase 1 Primary Objective: Pharmacodynamics: assessment by pH metry of the change in gastric pH (antacid activity) of Z0063, in comparison to the effect of Gaviscon Double Action Tablets, in healthy adult subjects. Secondary Objective: Safety: assessment of the clinical safety of Z0063, and Gaviscon Double Action Tablets, in healthy adult subjects.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Gaviscon

Condition Name

Condition Name for Gaviscon
Intervention Trials
Gastroesophageal Reflux Disease 3
Obesity 1
Gastroesophageal Reflux 1
Functional Dyspepsia 1
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Condition MeSH

Condition MeSH for Gaviscon
Intervention Trials
Gastroesophageal Reflux 4
Gastritis 1
Dyspepsia 1
Heartburn 1
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Clinical Trial Locations for Gaviscon

Trials by Country

Trials by Country for Gaviscon
Location Trials
United Kingdom 1
Denmark 1
Malaysia 1
France 1
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Clinical Trial Progress for Gaviscon

Clinical Trial Phase

Clinical Trial Phase for Gaviscon
Clinical Trial Phase Trials
Phase 4 1
Phase 2/Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Gaviscon
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 2
Recruiting 1
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Clinical Trial Sponsors for Gaviscon

Sponsor Name

Sponsor Name for Gaviscon
Sponsor Trials
Sanofi 2
Universitair Ziekenhuis Brussel 1
University Hospital Koge 1
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Sponsor Type

Sponsor Type for Gaviscon
Sponsor Trials
Other 5
Industry 2
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