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Role of Mosapride in Patients With Gastroesophageal Reflux Disease

This study has been completed.
Sponsor:
Collaborator:
Tomorrow Medical Foundation
Information provided by:
Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier:
NCT00729339
First received: July 31, 2008
Last updated: May 12, 2009
Last verified: May 2009
History of Changes
  Purpose

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.


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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Resource links provided by NLM:

MedlinePlus related topics: GERD
U.S. FDA Resources

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 ]

Enrollment: 114
Study Start Date: June 2008
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Locations
Taiwan
Lotung Poh-Ai Hospital
Lotung Town, Ilan County, Taiwan, 265
Sponsors and Collaborators
Lotung Poh-Ai Hospital
Tomorrow Medical Foundation
Investigators
Principal Investigator: Hwai-Jeng Lin, M.D. Lotung Poh-Ai Hospital
  More Information

No publications provided

Responsible Party: Hsin-Hong Chen/Superintendent, Lotung Poh-Ai Hospital
ClinicalTrials.gov Identifier: NCT00729339     History of Changes
Other Study ID Numbers: OMCP-97-011
Study First Received: July 31, 2008
Last Updated: May 12, 2009
Health Authority: Taiwan: Department of Health

Keywords provided by Lotung Poh-Ai Hospital:
Gastroesophageal reflux disease
Mosapride
Lansoprazole

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Lansoprazole
Mosapride
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 21, 2013