Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study

Last updated: April 23, 2025
Sponsor: Reckitt Benckiser Healthcare (UK) Limited
Overall Status: Completed

Phase

3

Condition

Gastroesophageal Reflux Disease (Gerd)

Esophageal Disorders

Colic

Treatment

Matching placebo tablets

Compound Sodium Alginate Double Action Chewable Tablets

Clinical Study ID

NCT01869491
GA1210
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Current evidence of symptomatic GERD in accord with the Montreal definition.

  • Patients must have had troublesome heartburn and/or regurgitation (with or withoutdyspepsia symptoms) of at least mild or moderate intensity on at least 5 days duringthe week before the start of screening.

Exclusion

Exclusion Criteria:

  • 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 morethan 6 kg in the last 6 months.

  • Female patients of childbearing potential who, for the duration of the study, areeither unwilling or unable to take adequate contraceptive precautions or areunwilling to be sexually abstinent.

  • Pregnancy or lactating mother.

  • Patients with a history and/or symptom profile suggestive of the following: anyother gastrointestinal (GI) disease, erosive GERD (Los Angeles classification gradesC-D), Barrett's oesophagus, acute peptic ulcer and/or ulcer complications,Zollinger-Ellison syndrome, gastric carcinoma, pyloric stenosis, oesophageal orgastric surgery, intestinal obstruction, current pernicious anaemia, indication forH. pylori eradication therapy, known gastrointestinal bleeding (hematochezia orhematemesis) within 3 months prior to the study, and severe diseases of other majorbody systems.

  • Patients who were observed at screening to have a hiatus hernia with a diameterwhich exceeds 3 cm.

  • Patients who have taken anti-cholinesterase drugs, traditional Chinese medicines fortreating gastrointestinal disease, ulcermin or misoprostol preparations within 7days prior to screening or throughout the study.

  • Patients who have taken proton pump inhibitors (PPIs) during the 10 days prior toscreening, prokinetics or H2 antagonists during the 5 days prior to screening orsystemic glucocorticosteroids, non-steroidal anti-inflammatory drugs (except for lowdose aspirin which can be given for cardioprotection) on more than 3 consecutivedays or PPI-based triple or quadruple therapy for eradication of H-pylori during thelast 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 functionand patients who require a low sodium diet.

  • Any previous history of allergy or known intolerance to any of the investigationalmedicinal products.

Study Design

Total Participants: 1107
Treatment Group(s): 2
Primary Treatment: Matching placebo tablets
Phase: 3
Study Start date:
June 05, 2013
Estimated Completion Date:
May 31, 2014

Connect with a study center

  • RB Investigational Sites

    Beijing,
    China

    Site Not Available

  • RB Investigational Sites

    Shanghai,
    China

    Site Not Available

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