Gastroesophageal Reflux DiseasePhase 3NCT01869491

Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study

A Phase 3 study testing Compound Sodium Alginate Double Action Chewable Tablets in people with Gastroesophageal Reflux Disease and Dyspepsia, run by Reckitt Benckiser Healthcare (UK) Limited at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Gastroesophageal Reflux Disease, Dyspepsia
What is being tested?: Compound Sodium Alginate Double Action Chewable Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,107 participants
Where: 2 sitesChina
Study dates: 5 Jun 2013to May 2014
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

2 sites in 1 country.

China2 sites

RB Investigational Sites
Beijing
RB Investigational Sites
Shanghai

Other trials in China

About this study

Official title: 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: Gastroesophageal Reflux Disease, Dyspepsia
Being tested: Compound Sodium Alginate Double Action Chewable Tablets, Matching placebo tablets
Keywords: Gastroesophageal Reflux Disease, GERD, Dyspepsia, Indigestion, Heartburn, Acid reflux, Compound Sodium Alginate Double Action Chewable Tablets, Gaviscon Double Action Tablets
Medical subject headings: Gastroesophageal Reflux, Dyspepsia, Heartburn

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Compound Sodium Alginate Double Action Chewable TabletsDrug
Also called Gaviscon Double Action Tablets
2 tablets four times daily
Matching placebo tabletsDrug
Also called Placebo
2 tablets four times daily

Study groups in NCT01869491
Study group	Role	What they receive
Sodium Alginate Double Action Chewable Tablets	Active comparator	Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily Receives: Drug: Compound Sodium Alginate Double Action Chewable Tablets
Matching placebo tablets	Placebo comparator	Matching placebo tablets, 2 tablets four times daily Receives: Drug: Matching placebo tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 7 days

Secondary outcomes (6)

Change From Baseline in RDQ Scores for the Dyspepsia Dimension
The change from baseline in RDQ symptom scores for the dyspepsia dimension after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The dyspepsia subscale of the RDQ has a minimum score of 0 and a maximum score of 20, with lower RDQ scores showing an improved outcome.
Measured: 7 days
Change From Baseline in RDQ Scores for the Heartburn Dimension
The change from baseline in RDQ symptom scores for the heartburn dimension after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The heartburn subscale of the RDQ has a minimum score of 0 and a maximum score of 20, with lower RDQ scores showing an improved outcome.
Measured: 7 days
Change From Baseline in RDQ Scores for the Regurgitation Dimension
The change from baseline in RDQ symptom scores for the regurgitation dimension after a 7-day treatment period of Compound Sodium Alginate Double Action Chewable Tablets compared with a matched placebo. The regurgitation subscale of the RDQ has a minimum score of 0 and a maximum score of 20, with lower RDQ scores showing an improved outcome.
Measured: 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
Comparison between the 2 cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) in OTE as a measure for patient's responsiveness/satisfaction, determined at Visit 3, the end-of-study visit.
Question 1 of the OTE assessed how the patients rated their responsiveness/satisfaction on a 15-point scale (from -7 = a very great deal worse to +7 = a very great deal better).
Measured: 7 days
OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
Comparison between the 2 cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) in OTE as a measure for patient's responsiveness/satisfaction, determined at Visit 3, the end-of-study visit.
Question 2 of the OTE addressed how patients perceived the importance of the change of the clinical status on a 7-point scale (from 1 = not important to 7 = extremely important).
Measured: 7 days
For Patients With Improvement Only: OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
For patients with improvement only, comparison between the 2 cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) in OTE as a measure for patient's responsiveness/satisfaction, determined at Visit 3, the end-of-study visit.
Question 2 of the OTE addressed how patients perceived the importance of the change of the clinical status on a 7-point scale (from 1 = not important to 7 = extremely important).
Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 2013May 2014

First posted5 Jun 2013 (estimated)
Study start5 Jun 2013
Primary completionMay 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01869491
Sponsor's protocol ID: GA1210
Status last verified: Apr 2025
First submitted: 31 May 2013
Last updated: 8 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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.
PubMed 26228097

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Gastroesophageal Reflux Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01869491
Acronym / sponsor ID: GA1210
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
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,107 participants (actual)
Lead sponsor: Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
Study start: 5 Jun 2013 (actual)
Primary completion: May 2014 (actual)
Study completion: May 2014 (actual)
First posted: 5 Jun 2013 (estimated)
Results: Posted 13 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Sodium Alginate Double Action Chewable Tablets	Active comparator	Drug: Compound Sodium Alginate Double Action Chewable TabletsCompound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
Matching placebo tablets	Placebo comparator	Drug: Matching placebo tabletsMatching placebo tablets, 2 tablets four times daily

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Compound Sodium Alginate Double Action Chewable TabletsAlso: Gaviscon Double Action Tablets2 tablets four times daily	Drug	Sodium Alginate Double Action Chewable Tablets
Matching placebo tabletsAlso: Placebo2 tablets four times daily	Drug	Matching placebo tablets

Primary outcome

Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension
Time frame: 7 days
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.

6 secondary outcomes

Change From Baseline in RDQ Scores for the Dyspepsia Dimension
Time frame: 7 days
Change From Baseline in RDQ Scores for the Heartburn Dimension
Time frame: 7 days
Change From Baseline in RDQ Scores for the Regurgitation Dimension
Time frame: 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
Time frame: 7 days
OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
Time frame: 7 days
For Patients With Improvement Only: OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
Time frame: 7 days

Results and safety

Results posted to the registry on 13 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sodium Alginate Double Action Chewable Tablets	552	531
Matching Placebo Tablets	555	531

Primary outcome: Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension

Time frame: 7 days. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	Sodium Alginate Double Action Chewable Tablets n = 536	Matching Placebo Tablets n = 537
Value	-1.27 (-1.37 to -1.16)	-1.06 (-1.17 to -0.95)

Sodium Alginate Double Action Chewable Tablets vs Matching Placebo Tablets: Mean Difference (Final Values): -0.21 (95% CI -0.31 to -0.11), p <0.0001, Mixed Models Analysis

Population analysed: Data are from patients in the intent-to-treat population, which included all patients who were recruited into the study and had at least partially completed RDQ questionnaire for the trial therapy period or were known to have withdrawn from the study due to poor efficacy.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 8 days, from after the first dose of IMP until no later than the day of the last dose of IMP +1. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sodium Alginate Double Action Chewable Tablets	1 of 549 (0.2%)	0 of 549 (0%)	0 of 549
Matching Placebo Tablets	0 of 550 (0%)	0 of 550 (0%)	0 of 550

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26228097Sun 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.

Related trials for Gastroesophageal Reflux Disease

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Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yuan Yaozong, MD, PhD principal investigator

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

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension (time frame: 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01869491, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2025.