Role of Mosapride in Patients With Gastroesophageal Reflux Disease

NCT ID: NCT00729339

Last Updated: 2009-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 114 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-05-31

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.

Conditions

Gastroesophageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

lansoprazole plus mosapride for the first month, and followed by lansoprazole plus placebo for the second month

Group Type: ACTIVE_COMPARATOR

mosapride for the first month and placebo for the 2nd month

Intervention Type: DRUG

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

2

lansoprazole plus placebo for the first month, and lansoprazole plus mosapride for the second month

Group Type: ACTIVE_COMPARATOR

placebo for the first and mosapride for the second month

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tomorrow Medical Foundation

OTHER

Sponsor Role: collaborator

Lotung Poh-Ai Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lotung Poh-Ai Hospital

Principal Investigators

Hwai-Jeng Lin, M.D.

Role: PRINCIPAL_INVESTIGATOR

Lotung Poh-Ai Hospital

Locations

Lotung Poh-Ai Hospital

Lotung Town, Ilan County, , Taiwan

Countries

Taiwan

Other Identifiers

OMCP-97-011

Identifier Type: -

Identifier Source: org_study_id