Efficacy and Safety of Sodium Alginate Oral Suspension to Treat Non-erosive Gastro-esophageal Reflux Disease
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
About 60% of patients with typical gastroesophageal reflux symptoms such as heartburn and
regurgitation are considered to have non-erosive reflux disease (NERD). Patients with NERD
show an overall poorer response to PPI treatment than patients with erosive reflux disease.
Sodium alginate oral suspension is a medication indicated for the relief of gastroesophageal
reflux symptoms. This multi-center, double blind, randomized trial aims to compare the
efficacy and safety profiles of sodium alginate oral suspension (50 mg/ml) 20 ml three times
daily with that of omeprazole (20 mg/capsule) 1 capsule once daily for the treatment of NERD
patients in Taiwan. Efficacy assessments include percentage of patients achieving adequate
relief of heartburn or regurgitation after 4 weeks treatment, improvement of reflux symptoms
as assessed by reflux disease questionnaire before and after treatment, and patients overall
satisfaction at the end of study. Safety assessments include incidence of adverse events and
change of the laboratory test results. The study hypothesis is that treatment with sodium
alginate is non-inferior to omeprazole in relieving heartburn or regurgitation symptoms of
the NERD patients.