Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study

Phase 3

Completed

Conditions: Gastroesophageal Reflux Disease
Dyspepsia

Interventions: Drug: Compound Sodium Alginate Double Action Chewable Tablets
Drug: Matching placebo tablets

Registration Number: NCT01869491

Lead Sponsor: Reckitt Benckiser Healthcare (UK) Limited

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 1107

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 5 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 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.
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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sodium Alginate Double Action Chewable Tablets	Compound Sodium Alginate Double Action Chewable Tablets	Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily
Matching placebo tablets	Matching placebo tablets	Matching placebo tablets, 2 tablets four times daily

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension	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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in RDQ Scores for the Dyspepsia Dimension	7 days	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.
Change From Baseline in RDQ Scores for the Heartburn Dimension	7 days	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.
Change From Baseline in RDQ Scores for the Regurgitation Dimension	7 days	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.
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	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).
OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms	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 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).
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	7 days	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).