Role of Mosapride in Patients With Gastroesophageal Reflux Disease - Full Text View

Sponsors and Collaborators:	Lotung Poh-Ai Hospital Tomorrow Medical Foundation
Information provided by:	Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier:	NCT00729339

Purpose

Gastroesophageal reflux disease (GERD) is a very common disease in the Western World. In Taiwan, this disease is increasing gradually because our 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.

Condition	Intervention	Phase
Gastroesophageal Reflux Disease	Drug: mosapride for the first month and placebo for the 2nd month Drug: placebo for the first and mosapride for the second month	Phase IV

MedlinePlus related topics: GERD

Drug Information available for: Lansoprazole Mosapride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Efficacy Study
Official Title:	Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Further study details as provided by Lotung Poh-Ai Hospital:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	June 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 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 30mg once per day for 2months mosapride 5mg thrice per day, for the first month placebo thrice per day, for the second month
2: Active Comparator 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 30mg once per day for 2months placebo thrice per day, for the first month mosapride 5mg thrice per day, for the second month

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.

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 Angels classification

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00729339

Contacts

Contact: Hwai-Jeng Lin, M.D.

886-3-954-3131 ext 5411

909010@mail.pohai.org.tw

Locations

Taiwan
Lotung Poh-Ai Hospital	Recruiting
Lotung Town, Ilan County, Taiwan, 265
Contact: Hwai-Jen Lin, M.D. 886-3-9543131 ext 5411 909010@mail.pohai.org.tw
Principal Investigator: Hwai-Jeng Lin, M.D.

Sponsors and Collaborators

Lotung Poh-Ai Hospital

Tomorrow Medical Foundation

Investigators

Principal Investigator:

Hwai-Jeng Lin, M.D.

Lotung Poh-Ai Hospital

More Information

Responsible Party:	Lotung Poh-Ai Hospital ( Hsin-Hong Chen/Superintendent )
Study ID Numbers:	OMCP-97-011
Study First Received:	July 31, 2008
Last Updated:	August 4, 2008
ClinicalTrials.gov Identifier:	NCT00729339
Health Authority:	Taiwan: Department of Health

Keywords provided by Lotung Poh-Ai Hospital:

Gastroesophageal reflux disease
Mosapride
Lansoprazole

Study placed in the following topic categories:

Deglutition Disorders
Esophageal Motility Disorders
Mosapride
Digestive System Diseases
Esophageal disorder

Gastrointestinal Diseases
Lansoprazole
Esophageal Diseases
Gastroesophageal Reflux
Serotonin

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action

Therapeutic Uses
Physiological Effects of Drugs
Gastrointestinal Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009