Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Gastroesophageal Reflux Disease Clinical Trial

Official title:

Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00729339
• Other study ID #: OMCP-97-011
• Status: Completed
• Phase: Phase 4
• First received: July 31, 2008
• Last updated: May 12, 2009
• Start date: June 2008
• Est. completion date: May 2009

Study information

• Verified date: May 2009
• Source: Lotung Poh-Ai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: May 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease

Intervention

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
• 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

Locations

Country	Name	City	State
Taiwan	Lotung Poh-Ai Hospital	Lotung Town, Ilan County

Sponsors (2)

Lead Sponsor	Collaborator
Lotung Poh-Ai Hospital	Tomorrow Medical Foundation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG)		before enrollment, one month after treatment, two months after treatment	No