NCT01872897

Compound Sodium Alginate Double Action Chewable Tablets 4-hour Esophageal pH Study in GERD Patients

A Multi-centred, Randomised, Open Label, Placebo-controlled, Two-period Crossover Study to Evaluate 4-hour Esophageal pH Change in GERD Patients After Administration of Compound Sodium Alginate Double Action Chewable Tablets or Matching Placebo Tablets

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 45 (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 to assess the effectiveness of the Compound Sodium Alginate Double Action Chewable Tablets compared to placebo on acidic reflux events into the esophagus in patients diagnosed with Gastroesophageal Reflux Disease (GERD).

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	Sodium Alginate Double Action Chewable Tablets	4 tablets as a single dose
DRUG	Placebo	4 tablets as a single dose

Timeline

• Start date: 2013-07-02
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2013-06-07
• Last updated: 2025-04-29
• Results posted: 2025-04-29

Locations

1 site across 1 country: China