Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study

NCT ID: NCT01869491

Last Updated: 2025-05-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1107 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-05
• Study Completion Date: 2014-05-31

Brief Summary

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).

Conditions

Gastroesophageal Reflux Disease; Dyspepsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Sodium Alginate Double Action Chewable Tablets

Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily

Group Type: ACTIVE_COMPARATOR

Compound Sodium Alginate Double Action Chewable Tablets

Intervention Type: DRUG

2 tablets four times daily

Matching placebo tablets

Matching placebo tablets, 2 tablets four times daily

Group Type: PLACEBO_COMPARATOR

Matching placebo tablets

Intervention Type: DRUG

2 tablets four times daily

Interventions

Compound Sodium Alginate Double Action Chewable Tablets

2 tablets four times daily

Intervention Type: DRUG

Matching placebo tablets

2 tablets four times daily

Intervention Type: DRUG

Other Intervention Names

Gaviscon Double Action Tablets; Placebo

Eligibility Criteria

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 5 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 suggestive of the following: any other gastrointestinal (GI) disease, erosive GERD (Los Angeles classification grades C-D), Barrett's oesophagus, 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 gastrointestinal bleeding (hematochezia or hematemesis) within 3 months prior to the study, and severe diseases of other major body systems.
• Patients who were observed at screening to have a hiatus hernia with a diameter which exceeds 3 cm.
• 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 proton pump inhibitors (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 (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 function and patients who require a low sodium diet.
• Any previous history of allergy or known intolerance to any of the investigational medicinal products.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Reckitt Benckiser Healthcare (UK) Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yuan Yaozong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Shanghai Jiao Tong University, School of Medicine, Shanghai, China

Locations

RB Investigational Sites

Beijing, , China

RB Investigational Sites

Shanghai, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 26228097 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GA1210

Identifier Type: -

Identifier Source: org_study_id