Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Conditions
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Gastroesophageal Reflux Disease

Intervention / Treatment
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* Drug: mosapride for the first month and placebo for the 2nd month
* Drug: placebo for the first and mosapride for the second month


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>lansoprazole plus mosapride for the first month, and followed by lansoprazole plus placebo for the second month | Drug: mosapride for the first month and placebo for the 2nd month<br>* 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<br>|
| Active Comparator: 2<br>lansoprazole plus placebo for the first month, and lansoprazole plus mosapride for the second month | Drug: placebo for the first and mosapride for the second month<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) |  | before enrollment, one month after treatment, two months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastroesophageal reflux disease, Mosapride, Lansoprazole