Role of Mosapride in Patients With Gastroesophageal Reflux Disease
Information source: Lotung Poh-Ai Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Gastroesophageal Reflux Disease
Intervention: mosapride for the first month and placebo for the 2nd month (Drug); placebo for the first and mosapride for the second month (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Lotung Poh-Ai Hospital Official(s) and/or principal investigator(s):
Hwai-Jeng Lin, M.D., Principal Investigator, Affiliation: Lotung Poh-Ai Hospital
Overall contact:
Hwai-Jeng Lin, M.D., Phone: 886-3-954-3131, Ext: 5411, Email: 909010@mail.pohai.org.tw
Summary
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.
Clinical Details
Official title: Role of Mosapride in Patients With Gastroesophageal Reflux Disease
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Crossover Assignment, Efficacy Study
Primary outcome: Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG)
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
Minimum age: 18 Years.
Maximum age: 90 Years.
Gender(s): Both.
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
Locations and Contacts
Hwai-Jeng Lin, M.D., Phone: 886-3-954-3131, Ext: 5411, Email: 909010@mail.pohai.org.tw
Lotung Poh-Ai Hospital, Lotung Town, Ilan County 265, Taiwan; Recruiting
Hwai-Jen Lin, M.D., Phone: 886-3-9543131, Ext: 5411, Email: 909010@mail.pohai.org.tw
Hwai-Jeng Lin, M.D., Principal Investigator
Additional Information
Starting date: June 2008
Ending date: July 2009
Last updated: August 4, 2008
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