Gastroesophageal Reflux DiseasePhase 3NCT01872897
Compound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients
A Phase 3 study testing Sodium Alginate Double Action Chewable Tablets in people with Gastroesophageal Reflux Disease, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- 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
- 45 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2013to Dec 2013
- 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
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-centred, Randomised, Open Label, Placebo-controlled, Two-period Crossover Study to Evaluate 4-hour Esophageal pH Change in GERD Patients After Administration of Compound Sodium Alginate Double Action Chewable Tablets or Matching Placebo Tablets
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
- Being tested
- Sodium Alginate Double Action Chewable Tablets, Placebo
- Keywords
- Gastroesophageal Reflux Disease, GERD, Acid reflux, Compound Sodium Alginate Double Action Chewable Tablet, Gaviscon Double Action Tablets
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Alginate Double Action Chewable TabletsDrug
Also called Gaviscon Double Action Tablets
4 tablets as a single dose
PlaceboDrug
4 tablets as a single dose
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Sodium Alginate Double Action Chewable Tablets; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0 to 4 hours post-dose
Secondary outcomes (10)
Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 5
Percentage of time during the 4-hour post-dosing period with pH below pH 5 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Measured: 0 to 4 hours post-dose
Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 4
Number of occasions during the 4-hour post-dosing period when pH falls below pH 4 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Measured: 0 to 4 hours post-dose
Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 5
Number of occasions during the 4-hour post-dosing period when pH falls below pH 5 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Measured: 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
Number of reflux episodes during the 4-hour post-dosing period with pH below pH 4 for at least 5 minutes for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Measured: 0 to 4 hours post-dose
Percentage of Time During the First Hour Post-dosing With pH Below pH 4
Percentage of time during the first hour post-dosing with pH below pH 4 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Measured: 0 to 1 hour post-dose
Percentage of Time During the First Hour Post-dosing With pH Below pH 5
Percentage of time during the first hour post-dosing with pH below pH 5 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Measured: 0 to 1 hour post-dose
Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 4
Number of occasions during the first hour post-dosing when pH falls below pH 4 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Measured: 0 to 1 hour post-dose
Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 5
Number of occasions during the first hour post-dosing when pH falls below pH 5 for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Measured: 0 to 1 hour post-dose
The Longest Reflux Time During the 4-hour Post-dosing Period (i.e. the Longest Period With pH Below pH 4)
The longest reflux time during the 4-hour post-dosing period (i.e. the longest period with pH below pH 4) for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets
Measured: 0 to 4 hours post-dose
The DeMeester Scores During the 4-hour Post-dosing Period
The DeMeester scores during the 4-hour post-dosing period for Compound Sodium Alginate Double Action Chewable Tablets versus matching placebo tablets.
The DeMeester score is a composite score of the acid exposure during a prolonged ambulatory pH monitoring. The parameters that constitute the score are number of reflux episodes, number of episodes longer than 5 minutes, longest reflux duration, total percentage of monitoring time with pH below 4, and the percentage of time with pH below 4 in an upright position and supine position, respectively. The DeMeester score is the sum of the scores calculated for each of the 6 parameters. A score more than 14.7 is considered abnormal acid reflux, scores between 14.7 and 100 are regarded as mild-to-moderate GERD, and a score greater than 100 is regarded as severe GERD.
Measured: 0 to 4 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2013 (estimated)
- Study start2 Jul 2013
- Primary completionDec 2013
- Study completionDec 2013
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.
- 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuan Yaozong, MD, PhD, Principal investigator, Shanghai Jiao Tong University, School of Medicine, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01872897
- Sponsor's protocol ID
- GA1202
- Status last verified
- Apr 2025
- First submitted
- 31 May 2013
- Last updated
- 29 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-centred, Randomised, Open Label, Placebo-controlled, Two-period Crossover Study to Evaluate 4-hour Esophageal pH Change in GERD Patients After Administration of Compound Sodium Alginate Double Action Chewable Tablets or Matching Placebo Tablets
- ClinicalTrials.gov ID
- NCT01872897
- Acronym / sponsor ID
- GA1202
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal Reflux Disease, GERD, Acid reflux, Compound Sodium Alginate Double Action Chewable Tablet, Gaviscon Double Action Tablets
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Study start
- 2 Jul 2013 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Jun 2013 (estimated)
- Results
- Posted 29 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium Alginate Double Action Chewable Tablets, then Placebo tablets | Active comparator | Drug: Sodium Alginate Double Action Chewable Tablets4 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 |
| Placebo tablets, then Sodium Alginate Double Action Chewable Tablets | Placebo comparator | Drug: Sodium Alginate Double Action Chewable Tablets, Drug: PlaceboSingle 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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:
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| Sodium Alginate Double Action Chewable TabletsAlso: Gaviscon Double Action Tablets4 tablets as a single dose | Drug | Placebo tablets, then Sodium Alginate Double Action Chewable Tablets, Sodium Alginate Double Action Chewable Tablets, then Placebo tablets |
| Placebo4 tablets as a single dose | Drug | Placebo tablets, then Sodium Alginate Double Action Chewable Tablets |
Primary outcome
Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 4
Time frame: 0 to 4 hours post-dose
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
10 secondary outcomes
Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 5
Time frame: 0 to 4 hours post-dose
Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 4
Time frame: 0 to 4 hours post-dose
Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 5
Time frame: 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
Time frame: 0 to 4 hours post-dose
Percentage of Time During the First Hour Post-dosing With pH Below pH 4
Time frame: 0 to 1 hour post-dose
Percentage of Time During the First Hour Post-dosing With pH Below pH 5
Time frame: 0 to 1 hour post-dose
Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 4
Time frame: 0 to 1 hour post-dose
Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 5
Time frame: 0 to 1 hour post-dose
The Longest Reflux Time During the 4-hour Post-dosing Period (i.e. the Longest Period With pH Below pH 4)
Time frame: 0 to 4 hours post-dose
The DeMeester Scores During the 4-hour Post-dosing Period
Time frame: 0 to 4 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sodium Alginate Double Action Chewable Tablets in people with Gastroesophageal Reflux Disease, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in China.
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 3 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 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 29 Apr 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?
Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 4 (time frame: 0 to 4 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2025.