Compound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients

NCT01872897 | Completed Phase 3 Results

• 1 other identifier: GA1202
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to assess the effectiveness of the Compound Sodium Alginate Double Action Chewable Tablets compared to placebo on acidic reflux events into the esophagus in patients diagnosed with Gastroesophageal Reflux Disease (GERD).

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal Reflux Disease; GERD; Acid reflux; Compound Sodium Alginate Double Action Chewable Tablet; Gaviscon Double Action Tablets

Outcome Measures

Primary Outcomes (1)

• Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 4

  The primary efficacy endpoint will be the percentage of time during the 4-hour post-dosing period with pH below pH 4 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets

  0 to 4 hours post-dose

Secondary Outcomes (10)

• Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 5

  0 to 4 hours post-dose

• Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 4

  0 to 4 hours post-dose

• Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 5

  0 to 4 hours post-dose

• Number of Reflux Episodes During the 4-hour Post-dosing Period With pH Below pH 4 for at Least 5 Minutes

  0 to 4 hours post-dose

• Percentage of Time During the First Hour Post-dosing With pH Below pH 4

  0 to 1 hour post-dose

Study Arms (2)

Sodium Alginate Double Action Chewable Tablets, then Placebo tablets

ACTIVE COMPARATOR

4 Compound Sodium Alginate Double Action Chewable Tablets administered as a single dose, followed by 7 days of Compound Sodium Alginate Double Action Chewable Tablets (two tablets four times daily), then a single dose of 4 Placebo tablets

Drug: Sodium Alginate Double Action Chewable Tablets

Placebo tablets, then Sodium Alginate Double Action Chewable Tablets

PLACEBO COMPARATOR

Single dose of 4 Placebo tablets, followed by 7 days of Compound Sodium Alginate Double Action Chewable Tablets (two tablets four times daily), then a single dose of 4 Compound Sodium Alginate Double Action Chewable Tablets

Drug: Sodium Alginate Double Action Chewable Tablets; Drug: Placebo

Interventions

Sodium Alginate Double Action Chewable Tablets DRUG

4 tablets as a single dose

Also known as: Gaviscon Double Action Tablets

Placebo tablets, then Sodium Alginate Double Action Chewable Tablets; Sodium Alginate Double Action Chewable Tablets, then Placebo tablets

Placebo DRUG

4 tablets as a single dose

Placebo tablets, then Sodium Alginate Double Action Chewable 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:

• meets the diagnostic criteria for GERD with a GERD history of frequent episodes of GERD-related symptoms during the last 2 months prior to study screening. The patient must also meet the following criteria:
• The only or main symptom is heartburn (burning feeling back of breast bone) and/or acid reflux. Symptoms persist or have occurred repeatedly for more than 2 months;
• As assessed by the Investigator at screening by questioning of the patient, the frequency of occurrence of heartburn is ≥ 3 days/week and the score of severity of heartburn in general is ≥ moderate within 3 weeks before screening

You may not qualify if:

• Patients who have a history of drug, solvent or alcohol abuse (weekly alcohol intake ≥ 140 g).
• 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 \[LA\] 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 the last 3 months, and severe diseases of other major body systems.
• Patients who are 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, ulcerlmin 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 (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 difficulty in swallowing.
• 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.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

Study Sites (1)

RB Investigational Sites

Shanghai, China

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

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: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2013
• First Posted: June 7, 2013
• Study Start: July 2, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 29, 2025
• Results First Posted: April 29, 2025

Record last verified: 2025-04

Locations

CN (1)