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

Tracking Information

First Received Date ^ICMJE

July 31, 2008

Last Updated Date

May 12, 2009

Start Date ^ICMJE

June 2008

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00729339 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Official Title ^ICMJE

Role of Mosapride in Patients With Gastroesophageal Reflux Disease

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Gastroesophageal Reflux Disease

Intervention ^ICMJE

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
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

Study Arm (s)

Active Comparator: 1
lansoprazole plus mosapride for the first month, and followed by lansoprazole plus placebo for the second month

Intervention: Drug: mosapride for the first month and placebo for the 2nd month
Active Comparator: 2
lansoprazole plus placebo for the first month, and lansoprazole plus mosapride for the second month

Intervention: Drug: placebo for the first and mosapride for the second month

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

114

Completion Date

May 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT00729339

Other Study ID Numbers ^ICMJE

OMCP-97-011

Has Data Monitoring Committee

Yes

Responsible Party

Hsin-Hong Chen/Superintendent, Lotung Poh-Ai Hospital

Study Sponsor ^ICMJE

Lotung Poh-Ai Hospital

Collaborators ^ICMJE

Tomorrow Medical Foundation

Investigators ^ICMJE

Principal Investigator:

Hwai-Jeng Lin, M.D.

Lotung Poh-Ai Hospital

Information Provided By

Lotung Poh-Ai Hospital

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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