Role of Mosapride in Patients With Gastroesophageal Reflux Disease

May 12, 2009 updated by: Lotung Poh-Ai Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Lotung Town, Ilan County, Taiwan, 265
        • Lotung Poh-Ai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
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
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
Active Comparator: 2
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
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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lotung Poh-Ai Hospital

Collaborators

Tomorrow Medical Foundation

Investigators

  • Principal Investigator: Hwai-jeng Lin, M.D., Lotung Poh-Ai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

July 31, 2008

First Submitted That Met QC Criteria

August 4, 2008

First Posted (Estimate)

August 7, 2008

Study Record Updates

Last Update Posted (Estimate)

May 13, 2009

Last Update Submitted That Met QC Criteria

May 12, 2009

Last Verified

May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OMCP-97-011

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastroesophageal Reflux Disease

Clinical Trials on mosapride for the first month and placebo for the 2nd month

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in El Salvador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe