Compound Sodium Alginate Double Action Chewable Tablet Symptomatic Relief Study

Reckitt Benckiser

Status and phase: Completed; Phase 3

Conditions: Dyspepsia; Gastroesophageal Reflux Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01869491

GA1210

Details and patient eligibility

About

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).

Enrollment: 1,107 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,107 participants in 2 patient groups, including a placebo group

Sodium Alginate Double Action Chewable Tablets

Active Comparator group

Description:

Compound Sodium Alginate Double Action Chewable Tablets, 2 tablets four times daily

Treatment:

Drug: Compound Sodium Alginate Double Action Chewable Tablets

Matching placebo tablets

Placebo Comparator group

Description:

Matching placebo tablets, 2 tablets four times daily

Treatment:

Drug: Matching placebo tablets