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CompletedNCT01872897Updated Apr 29, 2025Results posted

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

A Phase 3 interventional study of Sodium Alginate Double Action Chewable Tablets and Placebo in Gastroesophageal Reflux Disease, sponsored by Reckitt Benckiser Healthcare (UK) Limited. Completed at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-29.

Sponsored by Reckitt Benckiser Healthcare (UK) Limited · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Gastroesophageal Reflux Disease

Keywords

  • Gastroesophageal Reflux Disease
  • GERD
  • Acid reflux
  • Compound Sodium Alginate Double Action Chewable Tablet
  • Gaviscon Double Action Tablets
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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:

    1. 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;
    2. 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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Active comparator
    Sodium Alginate Double Action Chewable Tablets, then Placebo tablets

    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 comparator
    Placebo tablets, then Sodium Alginate Double Action Chewable Tablets

    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

  • DrugSodium Alginate Double Action Chewable Tablets

    4 tablets as a single dose

    Also known as: Gaviscon Double Action Tablets

  • DrugPlacebo

    4 tablets as a single dose

05

What researchers measure

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

    Time frame: 0 to 4 hours post-dose

Secondary outcomes

  1. 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

    Time frame: 0 to 4 hours post-dose

  2. 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

    Time frame: 0 to 4 hours post-dose

  3. 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

    Time frame: 0 to 4 hours post-dose

  4. 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

    Time frame: 0 to 4 hours post-dose

  5. 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

    Time frame: 0 to 1 hour post-dose

  6. 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

    Time frame: 0 to 1 hour post-dose

  7. 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

    Time frame: 0 to 1 hour post-dose

  8. 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

    Time frame: 0 to 1 hour post-dose

  9. 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

    Time frame: 0 to 4 hours post-dose

  10. 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.

    Time frame: 0 to 4 hours post-dose

06

Results

Posted Apr 29, 2025

Participant flow

Participant flow — Overall Study
MilestoneGroup AGroup B
Started2223
Completed2123
Not completed10
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryPercentage 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

Time frame:
0 to 4 hours post-dose
Reported as:
Least squares mean · percentage of time with pH below pH 4
Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 4
percentage of time with pH below pH 4Sodium Alginate Double Action Chewable TabletsPlacebo Tablets
Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 45.14 (-0.27 to 10.56)14.94 (9.52 to 20.35)
Statistical analysis
  • Sodium Alginate Double Action Chewable Tablets vs Placebo Tablets · Mixed Models Analysis · p = 0.0003 · Mean difference (final values): -9.79 · 95% CI -14.85 to -4.74
SecondaryPercentage 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

Time frame:
0 to 4 hours post-dose
Reported as:
Least squares mean · percentage of time with pH below pH 5
Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 5
percentage of time with pH below pH 5Sodium Alginate Double Action Chewable TabletsPlacebo Tablets
Percentage of Time During the 4-hour Post-dosing Period With pH Below pH 510.40 (3.40 to 17.40)26.16 (19.16 to 33.16)
Statistical analysis
  • Sodium Alginate Double Action Chewable Tablets vs Placebo Tablets · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -15.76 · 95% CI -22.82 to -8.71
SecondaryNumber 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

Time frame:
0 to 4 hours post-dose
Reported as:
Least squares mean · Number of occasions pH fell below 4
Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 4
Number of occasions pH fell below 4Sodium Alginate Double Action Chewable TabletsPlacebo Tablets
Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 411.5 (3.4 to 19.6)30.9 (22.8 to 39.1)
Statistical analysis
  • Sodium Alginate Double Action Chewable Tablets vs Placebo Tablets · Mixed Models Analysis · p = 0.0004 · Median difference (final values): -19.4 · 95% CI -29.6 to -9.2
SecondaryNumber 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

Time frame:
0 to 4 hours post-dose
Reported as:
Least squares mean · Number of occasions pH fell below 5
Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 5
Number of occasions pH fell below 5Sodium Alginate Double Action Chewable TabletsPlacebo Tablets
Number of Occasions During the 4-hour Post-dosing Period When pH Falls Below pH 517.3 (9.5 to 25.1)33.6 (25.8 to 41.4)
Statistical analysis
  • Sodium Alginate Double Action Chewable Tablets vs Placebo Tablets · Mixed Models Analysis · p = 0.0019 · Mean difference (final values): -16.3 · 95% CI -26.2 to -6.4
SecondaryNumber 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

Time frame:
0 to 4 hours post-dose
Reported as:
Least squares mean · Number of reflux episodes
Number of Reflux Episodes During the 4-hour Post-dosing Period With pH Below pH 4 for at Least 5 Minutes
Number of reflux episodesSodium Alginate Double Action Chewable TabletsPlacebo Tablets
Number of Reflux Episodes During the 4-hour Post-dosing Period With pH Below pH 4 for at Least 5 Minutes0.6 (-0.1 to 1.3)1.4 (0.7 to 2.1)
Statistical analysis
  • Sodium Alginate Double Action Chewable Tablets vs Placebo Tablets · Mixed Models Analysis · p = 0.0290 · Mean difference (final values): -0.8 · 95% CI -1.6 to -0.1
SecondaryPercentage 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

Time frame:
0 to 1 hour post-dose
Reported as:
Least squares mean · percentage of time with pH below pH 4
Percentage of Time During the First Hour Post-dosing With pH Below pH 4
percentage of time with pH below pH 4Sodium Alginate Double Action Chewable TabletsPlacebo Tablets
Percentage of Time During the First Hour Post-dosing With pH Below pH 42.00 (-3.43 to 7.44)16.41 (10.98 to 21.84)
Statistical analysis
  • Sodium Alginate Double Action Chewable Tablets vs Placebo Tablets · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -14.40 · 95% CI -20.57 to -8.23
SecondaryPercentage 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

Time frame:
0 to 1 hour post-dose
Reported as:
Least squares mean · percentage of time with pH below pH 5
Percentage of Time During the First Hour Post-dosing With pH Below pH 5
percentage of time with pH below pH 5Sodium Alginate Double Action Chewable TabletsPlacebo Tablets
Percentage of Time During the First Hour Post-dosing With pH Below pH 54.23 (-2.82 to 11.29)27.60 (20.55 to 34.65)
Statistical analysis
  • Sodium Alginate Double Action Chewable Tablets vs Placebo Tablets · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -23.37 · 95% CI -31.55 to -15.19
SecondaryNumber 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

Time frame:
0 to 1 hour post-dose
Reported as:
Least squares mean · Number of occasions pH fell below 4
Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 4
Number of occasions pH fell below 4Sodium Alginate Double Action Chewable TabletsPlacebo Tablets
Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 41.7 (-0.6 to 4.0)9.1 (6.7 to 11.4)
Statistical analysis
  • Sodium Alginate Double Action Chewable Tablets vs Placebo Tablets · Mixed Models Analysis · p = <0.0001 · Mean difference (final values): -7.3 · 95% CI -10.0 to -4.6
SecondaryNumber 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

Time frame:
0 to 1 hour post-dose
Reported as:
Least squares mean · Number of occasions pH fell below 5
Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 5
Number of occasions pH fell below 5Sodium Alginate Double Action Chewable TabletsPlacebo Tablets
Number of Occasions During the First Hour Post-dosing When pH Falls Below pH 53.1 (0.8 to 5.4)9.5 (7.2 to 11.8)
Statistical analysis
  • Sodium Alginate Double Action Chewable Tablets vs Placebo Tablets · Mixed Models Analysis · p = 0.0001 · Mean difference (final values): -6.4 · 95% CI -9.4 to -3.3
SecondaryThe 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

Time frame:
0 to 4 hours post-dose
Reported as:
Least squares mean · minutes
The Longest Reflux Time During the 4-hour Post-dosing Period (i.e. the Longest Period With pH Below pH 4)
minutesSodium Alginate Double Action Chewable TabletsPlacebo Tablets
The Longest Reflux Time During the 4-hour Post-dosing Period (i.e. the Longest Period With pH Below pH 4)3.3 (-1.3 to 7.9)9.6 (5.1 to 14.2)
Statistical analysis
  • Sodium Alginate Double Action Chewable Tablets vs Placebo Tablets · Mixed Models Analysis · p = 0.0075 · Mean difference (final values): -6.3 · 95% CI -10.9 to -1.8
SecondaryThe 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.

Time frame:
0 to 4 hours post-dose
Reported as:
Least squares mean · score on a scale
The DeMeester Scores During the 4-hour Post-dosing Period
score on a scaleSodium Alginate Double Action Chewable TabletsPlacebo Tablets
The DeMeester Scores During the 4-hour Post-dosing Period14.842 (2.125 to 27.560)38.987 (26.270 to 51.704)
Statistical analysis
  • Sodium Alginate Double Action Chewable Tablets vs Placebo Tablets · Mixed Models Analysis · p = 0.0007 · Mean difference (final values): -24.145 · 95% CI -37.432 to -10.858

Adverse events

Collected over Up to 19 days, from the time informed consent was provided until the Day 7 (+/- 2 days) visit. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Group A0/22 (0%)0/22 (0%)0/22 (0%)
Group B0/23 (0%)0/23 (0%)2/23 (8.7%)
Most frequent other events
Most frequent other events
EventGroup AGroup B
White blood cell count decreasedInvestigations0/222/23

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Group AGroup BTotal
<=18 years000
Between 18 and 65 years212344
>=65 years101
Age, Continuous
Age, Continuous(years)Group AGroup BTotal
Mean41.6 ± 15.2739.3 ± 16.9040.4 ± 15.98
Sex: Female, Male
Sex: Female, Male(Participants)Group AGroup BTotal
Female11819
Male111526
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Group AGroup BTotal
Caucasian000
Asian222345
Afro-Caribbean000
Other000
Region of Enrollment
Region of Enrollment(participants)Group AGroup BTotal
China222345
07

Study locations

1 site
  • RB Investigational Sites
    Shanghai, China
08

References and documents

Study documents

  • Study protocol · Jun 4, 2013
  • Statistical analysis plan · Jul 17, 2014

Documents are hosted by the registry — open the source record to download them.

09

Registry details

Key details

Study ID
NCT01872897
Lead sponsor
Reckitt Benckiser Healthcare (UK) Limited
Responsible party
Sponsor
First posted
Jun 7, 2013
Start date
Jul 2, 2013
Primary completion
Dec 2013
Completion
Dec 2013
Results posted
Apr 29, 2025
Last update
Apr 29, 2025

Study contacts

Yuan Yaozong, MD, PhD
principal investigator · Shanghai Jiao Tong University, School of Medicine, Shanghai, China

Oversight

Data monitoring committee
No
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