Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study

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

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).

Study Overview

• Status: Completed
• Conditions: Dyspepsia; Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: Compound Sodium Alginate Double Action Chewable Tablets; Drug: Matching placebo tablets

• Study Type: Interventional
• Enrollment (Actual): 1107
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • RB Investigational Sites
  • Shanghai, China
    • RB Investigational Sites

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sodium Alginate Double Action Tablets; Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily	Drug: Compound Sodium Alginate Double Action Chewable Tablets; 2 tablets four times daily; Other Names: Gaviscon Double Action Tablets
Placebo Comparator: Matching placebo tablets; Matching placebo tablets, 2 tablets four times daily	Drug: Matching placebo tablets; 2 tablets four times daily; Other Names: Placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Reckitt Benckiser Healthcare (UK) Limited
• Investigators: Principal Investigator: Yuan Yaozong, MD, PhD, Shanghai Jiaotong University, School of Medicine, Shanghai, China

Publications and helpful links

General Publications

• Sun J, Yang C, Zhao H, Zheng P, Wilkinson J, Ng B, Yuan Y. 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. Aliment Pharmacol Ther. 2015 Oct;42(7):845-54. doi: 10.1111/apt.13334. Epub 2015 Jul 31.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: May 31, 2013
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (Estimate): June 5, 2013

Study Record Updates

• Last Update Posted (Estimate): May 13, 2014
• Last Update Submitted That Met QC Criteria: May 12, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: GERD; Gastroesophageal Reflux Disease; Heartburn; Dyspepsia; Indigestion; Acid reflux; Compound Sodium Alginate Double Action Chewable Tablets; Gaviscon Double Action Tablets
• Additional Relevant MeSH Terms: Digestive System Diseases; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Dyspepsia; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Antacids; Alginate, aluminium hydroxide, magnesium trisilicate, sodium bicarbonate drug combination
• Other Study ID Numbers: GA1210

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No