NCT00729339

Role of Mosapride in Patients With Gastroesophageal Reflux Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 114 (actual)
• Sponsor: Lotung Poh-Ai Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In Taiwan, this disease is increasing gradually because the investigators' eating style is closing to Western world. Proton pump is the main drug for patients with GERD in the past two decades. Prokinetic agent is an important adjuvant to the therapy of GERD. This study aims to evaluate the role of prokinetic agent in the management of GERD.

Detailed description

This is a randomized, double-blind, cross-over study. FSSG is obtained at the beginning, one month and two months of the study. This study plans to enroll 100 patients with symptoms of GERD (acid regurgitation, belching, dysphagia). After receiving endoscopic examination, a frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) is obtained from these patients. Fifty patients receive lansoprazole 30 mg once plus mosapride 5 mg tid daily in the first month; and lansoprazole 30 mg once plus placebo tid daily in the second month. Another fifty patients receive lansoprazole 30 mg once plus placebo tid daily in the first month; and lansoprazole 30 mg once plus mosapride 5 mg tid daily in the second month.

Conditions

• Gastroesophageal Reflux Disease

Interventions

Type	Name	Description
DRUG	mosapride for the first month and placebo for the 2nd month	lansoprazole 30 mg once per day for 2 months mosapride 5 mg thrice per day, for the first month placebo thrice per day, for the second month
DRUG	placebo for the first and mosapride for the second month	lansoprazole 30 mg once per day for 2 months placebo thrice per day, for the first month mosapride 5 mg thrice per day, for the second month

Timeline

• Start date: 2008-06-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2008-08-07
• Last updated: 2009-05-13

Locations

1 site across 1 country: Taiwan