Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Phase 4

Completed

• Conditions: Gastroesophageal Reflux Disease
• Interventions: Drug: mosapride for the first month and placebo for the 2nd month; Drug: placebo for the first and mosapride for the second month

• Registration Number: NCT00729339
• Lead Sponsor: Lotung Poh-Ai Hospital

Brief 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.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-31
• Study First Submitted QC: 2008-08-04
• Study First Posted: 2008-08-07
• Primary Completion: 2009-04
• Status Verified: 2009-05
• Study Completion: 2009-05
• Last Update Submitted: 2009-05-12
• Last Update Posted: 2009-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

Inclusion Criteria

• Aged between 18 and 90 years old
• Outpatients
• Characteristic GERD symptoms: acid regurgitation, heart burn, or belching
• Erosive esophagitis on upper digestive endoscopy, based on Los Angeles classification

Exclusion Criteria

• History of allergy to lansoprazole or mosapride
• Pregnant or lactating women
• Uremia
• Decompensated liver disease
• Age under 18 and over 90 years-old
• Lack of informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	mosapride for the first month and placebo for the 2nd month	lansoprazole plus mosapride for the first month, and followed by lansoprazole plus placebo for the second month
2	placebo for the first and mosapride for the second month	lansoprazole plus placebo for the first month, and lansoprazole plus mosapride for the second month

Primary Outcome Measures

Name	Time	Method
Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG)	before enrollment, one month after treatment, two months after treatment

Trial Locations

Locations (1)

Lotung Poh-Ai Hospital; 🇨🇳 Lotung Town, Ilan County, Taiwan

Lotung Poh-Ai Hospital

🇨🇳Lotung Town, Ilan County, Taiwan