Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Reckitt Benckiser Healthcare (UK) Limited
ClinicalTrials.gov Identifier:
NCT01869491
First received: May 31, 2013
Last updated: May 12, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Gastroesophageal Reflux Disease
Dyspepsia
Drug: Compound Sodium Alginate Double Action Chewable Tablets
Drug: Matching placebo tablets
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Reckitt Benckiser Healthcare (UK) Limited:

Primary Outcome Measures:
  • Change from baseline in GERD dimension [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    The primary study endpoint is to compare 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


Secondary Outcome Measures:
  • Change from baseline in RDQ scores for dyspepsia dimension [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Comparison between the two cohorts (Compound Sodium Alginate Double Action Chewable Tablets and matching placebo) for a 7-day treatment period for change from baseline in RDQ scores for dyspepsia dimension


Enrollment: 1107
Study Start Date: June 2013
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sodium Alginate Double Action Tablets
Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
Drug: Compound Sodium Alginate Double Action Chewable Tablets
2 tablets four times daily
Other Name: Gaviscon Double Action Tablets
Placebo Comparator: Matching placebo tablets
Matching placebo tablets, 2 tablets four times daily
Drug: Matching placebo tablets
2 tablets four times daily
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 five days during the week before the start of screening

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 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 and/or discovered on endoscopy suggestive of the following: any other gastrointestinal (GI) disease, erosive GERD (Los Angeles [LA] classification grades C-D), Barrett's esophagus, 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 gastro-intestinal bleeding (hematochezia or hematemesis) within the last 3 months, and severe diseases of other major body systems.
  • Patients who were observed on endoscopy to have a hiatus hernia with a diameter which exceeds 3cm.
  • 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 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 (NSAIDs, 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 diseases and patients who require a low sodium diet.
  • Any previous history of allergy or known intolerance to any of the IMP's
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869491

Locations
China
RB Investigational Sites
Beijing, China
RB Investigational Sites
Shanghai, China
Sponsors and Collaborators
Reckitt Benckiser Healthcare (UK) Limited
Investigators
Principal Investigator: Yuan Yaozong, MD, PhD Shanghai Jiaotong University, School of Medicine, Shanghai, China
  More Information

No publications provided

Responsible Party: Reckitt Benckiser Healthcare (UK) Limited
ClinicalTrials.gov Identifier: NCT01869491     History of Changes
Other Study ID Numbers: GA1210
Study First Received: May 31, 2013
Last Updated: May 12, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Reckitt Benckiser Healthcare (UK) Limited:
Gastroesophageal Reflux Disease
GERD
Dyspepsia
Indigestion
Heartburn
Acid reflux
Compound Sodium Alginate Double Action Chewable Tablets
Gaviscon Double Action Tablets

Additional relevant MeSH terms:
Gastroesophageal Reflux
Dyspepsia
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Alginic acid
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014