Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study

NCT01869491 | Completed Phase 3 Results

• 1 other identifier: GA1210
• Study Type: interventional
• Target: 1,107
• Locations: 1 country
• Sites: 2

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

Keywords

Gastroesophageal Reflux Disease; GERD; Dyspepsia; Indigestion; Heartburn; Acid reflux; Compound Sodium Alginate Double Action Chewable Tablets; Gaviscon Double Action Tablets

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension

  The primary study endpoint is 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. The RDQ is a 12-item self-administered questionnaire designed to assess the frequency and severity of heartburn, acid regurgitation and dyspepsia symptoms, with a minimum score of 0 and a maximum score of 60, with lower RDQ scores showing an improved outcome. The heartburn and acid regurgitation subscales can be combined into a GERD dimension, which has a minimum score of 0 and a maximum score of 40, with lower RDQ scores showing an improved outcome.

  7 days

Secondary Outcomes (6)

• Change From Baseline in RDQ Scores for the Dyspepsia Dimension

  7 days

• Change From Baseline in RDQ Scores for the Heartburn Dimension

  7 days

• Change From Baseline in RDQ Scores for the Regurgitation Dimension

  7 days

• Overall Treatment Evaluation (OTE) as a Measure of Patient Responsiveness/Satisfaction: Question 1 - Patient's Evaluation of the Change in Symptoms Over the Last 7 Days

  7 days

• OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms

  7 days

Study Arms (2)

Sodium Alginate Double Action Chewable Tablets

ACTIVE COMPARATOR

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

Drug: Compound Sodium Alginate Double Action Chewable Tablets

Matching placebo tablets

PLACEBO COMPARATOR

Matching placebo tablets, 2 tablets four times daily

Drug: Matching placebo tablets

Interventions

Compound Sodium Alginate Double Action Chewable Tablets DRUG

2 tablets four times daily

Also known as: Gaviscon Double Action Tablets

Sodium Alginate Double Action Chewable Tablets

Matching placebo tablets DRUG

2 tablets four times daily

Also known as: Placebo

Matching placebo tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

Study Sites (2)

RB Investigational Sites

Beijing, China

Location

RB Investigational Sites

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 26228097 DERIVED

MeSH Terms

Conditions

Gastroesophageal Reflux; Dyspepsia; Heartburn

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Data Controller
• Organization: Reckitt Benckiser

clinicaldatacontroller@reckitt.com

Study Officials

• Yuan Yaozong, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 5, 2013
• Study Start: June 5, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 8, 2025
• Results First Posted: March 13, 2025

Record last verified: 2025-04

Locations

CN (2)