NCT02623062

Compound Sodium Alginate Oral Suspension Sachet Symptomatic Relief Study

A Multi-centred, Randomised, Double-blind, Two Arms, Parallel Group, Placebo-controlled Study to Assess the Effect of Compound Sodium Alginate Oral Suspension Sachet in Patients With Reflux Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 644 (actual)
• Sponsor: Reckitt Benckiser Healthcare (UK) Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted in China to provide evidence for inclusion in applications to competent authorities that the Compound Sodium Alginate Oral Suspension sachet is effective in managing the symptoms of heartburn and acid regurgitation in patients with gastro-esophageal reflux disease (GERD).

Detailed description

This is a multi-centre, randomised, double blind, two arm, parallel group, placebo-controlled clinical trial in patients with moderate to severe and frequent GERD symptoms. After signing a written informed consent, patients will undergo a screening period of up to 7 days. Patients who satisfy the study entry requirements within 7 days of consent, will be randomised to receive either Compound Sodium Alginate Oral Suspension sachets (20ml four times daily) or matching placebo sachets (20ml four times daily),for a 7- day treatment period. At the beginning and end of the treatment period, patients will be required to complete the Reflux Disease Questionnaire (RDQ). In addition, at the end of the 7 (-1 day to +2 days) day treatment period, patients will be required to complete the Overall Treatment Evaluation.

Conditions

• Gastro-esophageal Reflux Disease (GERD)

Interventions

Type	Name	Description
DRUG	Compound Sodium Alginate Oral Suspension sachet	Contents of 2 sachets taken four times daily for 7 days
DRUG	Matched placebo	Contents of 2 sachets taken four times daily for 7 days

Timeline

• Start date: 2013-12-01
• Primary completion: 2016-03-01
• Completion: 2016-05-01
• First posted: 2015-12-07
• Last updated: 2016-06-03

Locations

1 site across 1 country: China