Back to resultsRole of Mosapride in Patients With Gastroesophageal Reflux Disease
Primary Purpose
Gastroesophageal Reflux Disease
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
mosapride for the first month and placebo for the 2nd month
placebo for the first and mosapride for the second month
Sponsored by
About this trial
This is an interventional treatment trial for Gastroesophageal Reflux Disease focused on measuring Gastroesophageal reflux disease, Mosapride, Lansoprazole
Eligibility 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
Sites / Locations
- Lotung Poh-Ai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
1
2
Arm Description
lansoprazole plus mosapride for the first month, and followed by lansoprazole plus placebo for the second month
lansoprazole plus placebo for the first month, and lansoprazole plus mosapride for the second month
Outcomes
Primary Outcome Measures
Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG)
Secondary Outcome Measures
Full Information
NCT ID
NCT00729339
First Posted
July 31, 2008
Last Updated
May 12, 2009
Sponsor
Lotung Poh-Ai Hospital
Collaborators
Tomorrow Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00729339
Brief Title
Role of Mosapride in Patients With Gastroesophageal Reflux Disease
Official Title
Role of Mosapride in Patients With Gastroesophageal Reflux Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2009
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Lotung Poh-Ai Hospital
Collaborators
Tomorrow Medical Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux Disease
Keywords
Gastroesophageal reflux disease, Mosapride, Lansoprazole
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
lansoprazole plus mosapride for the first month, and followed by lansoprazole plus placebo for the second month
Arm Title
2
Arm Type
Active Comparator
Arm Description
lansoprazole plus placebo for the first month, and lansoprazole plus mosapride for the second month
Intervention Type
Drug
Intervention Name(s)
mosapride for the first month and placebo for the 2nd month
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo for the first and mosapride for the second month
Intervention Description
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
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hwai-Jeng Lin, M.D.
Organizational Affiliation
Lotung Poh-Ai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lotung Poh-Ai Hospital
City
Lotung Town, Ilan County
ZIP/Postal Code
265
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Role of Mosapride in Patients With Gastroesophageal Reflux Disease
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