Clinical trial NCT01869491: Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Dyspepsia
Keywords: Gastroesophageal Reflux Disease
GERD
Dyspepsia
Indigestion
Heartburn
Acid reflux
Compound Sodium Alginate Double Action Chewable Tablets
Gaviscon Double Action Tablets
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
First posted: 2013-06-05
Enrollment: 1107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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 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.

Primary outcomes:
measure: Change From Baseline in Reflux Disease Questionnaire (RDQ) Scores for the GERD Dimension
timeFrame: 7 days
Secondary outcomes:
measure: Change From Baseline in RDQ Scores for the Dyspepsia Dimension
timeFrame: 7 days
measure: Change From Baseline in RDQ Scores for the Heartburn Dimension
timeFrame: 7 days
measure: Change From Baseline in RDQ Scores for the Regurgitation Dimension
timeFrame: 7 days
measure: 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
timeFrame: 7 days
measure: OTE as a Measure of Patient Responsiveness/Satisfaction: Question 2 - Patient's Evaluation of the Importance of the Change in Symptoms
timeFrame: 7 days
measure: 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
timeFrame: 7 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: RB Investigational Sites
city: Shanghai
country: China
facility: RB Investigational Sites
Study officials:
affiliation: Shanghai Jiao Tong University, School of Medicine, Shanghai, China
name: Yuan Yaozong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sun J, Yang C, Zhao H, Zheng P, Wilkinson J, Ng B, Yuan Y. Randomised clinical trial: the clinical efficacy and safety of an alginate-antacid (Gaviscon Double Action) versus placebo, for decreasing upper gastrointestinal symptoms in symptomatic gastroesophageal reflux disease (GERD) in China. Aliment Pharmacol Ther. 2015 Oct;42(7):845-54. doi: 10.1111/apt.13334. Epub 2015 Jul 31.