Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study

Study Overview
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Brief Summary
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This study is being conducted to provide evidence that Compound Sodium Alginate Double Action Chewable Tablets are effective in managing the symptoms of heartburn, acid regurgitation and dyspepsia in patients with Gastroesophageal Reflux Disease (GERD).

Official Title
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A Multi-centre, Randomised, Double-blind, Two Arm, Parallel Group, Placebo-controlled Study to Assess the Effect of Compound Sodium Alginate Double Action Chewable Tablets in Patients With Gastro-esophageal Reflux Disease

Conditions
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Gastroesophageal Reflux Disease, Dyspepsia

Intervention / Treatment
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* Drug: Compound Sodium Alginate Double Action Chewable Tablets
* Drug: Matching placebo tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Current evidence of symptomatic GERD in accord with the Montreal definition Patients must have had troublesome heartburn and/or regurgitation (with or without dyspepsia symptoms) of at least mild or moderate intensity on at least five days during the week before the start of screening Exclusion Criteria: Patients who have a history of drug, solvent or alcohol abuse Patients who have suffered cardiac chest pain within the last year. Patients who have suffered a recent, significant unexplained weight loss of more than 6 Kg in the last 6 months. Female patients of childbearing potential who, for the duration of the study, are either unwilling or unable to take adequate contraceptive precautions or are unwilling to be sexually abstinent Pregnancy or lactating mother. Patients with a history and/or symptom profile and/or discovered on endoscopy suggestive of the following: any other gastrointestinal (GI) disease, erosive GERD (Los Angeles [LA] classification grades C-D), Barrett's esophagus, acute peptic ulcer and/or ulcer complications, Zollinger-Ellison syndrome, gastric carcinoma, pyloric stenosis, oesophageal or gastric surgery, intestinal obstruction, current pernicious anaemia, indication for H-pylori eradication therapy, known gastro-intestinal bleeding (hematochezia or hematemesis) within the last 3 months, and severe diseases of other major body systems. Patients who were observed on endoscopy to have a hiatus hernia with a diameter which exceeds 3cm. Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines for treating gastrointestinal disease, ulcermin or misoprostol preparations within 7 days prior to screening or throughout the study. Patients who have taken PPIs during the 10 days prior to screening, prokinetics or H2 antagonists during the 5 days prior to screening or systemic glucocorticosteroids, non-steroidal anti-inflammatory drugs (NSAIDs, except for low dose aspirin which can be given for cardioprotection) on more than 3 consecutive days or PPI-based triple or quadruple therapy for eradication of H-pylori during the last 28 days. Patients taking or requiring to take macrolide antibiotics, such as erythromycin, azithromycin, from the day before screening. Patients with known hypophosphataemia, phenylketonuria or hypercalcaemia. Patients with severe constipation, or history of intestinal obstruction. In the opinion of the Investigator, patients with damaged heart or kidney diseases and patients who require a low sodium diet. Any previous history of allergy or known intolerance to any of the IMP's

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium Alginate Double Action Tablets<br>Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily | Drug: Compound Sodium Alginate Double Action Chewable Tablets<br>* 2 tablets four times daily<br>* Other names: Gaviscon Double Action Tablets;|
| Placebo Comparator: Matching placebo tablets<br>Matching placebo tablets, 2 tablets four times daily | Drug: Matching placebo tablets<br>* 2 tablets four times daily<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in GERD dimension | The primary study endpoint is to compare the change from baseline in RDQ symptom scores for the GERD dimension (heartburn and regurgitation) after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in RDQ scores for dyspepsia dimension | Comparison between the two cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) for a 7-day treatment period for change from baseline in RDQ scores for dyspepsia dimension | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GERD, Gastroesophageal Reflux Disease, Dyspepsia, Indigestion, Heartburn, Acid reflux, Compound Sodium Alginate Double Action Chewable Tablets, Gaviscon Double Action Tablets