Role of Mosapride in Patients With Gastroesophageal Reflux Disease
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|ClinicalTrials.gov Identifier: NCT00729339|
Recruitment Status : Completed
First Posted : August 7, 2008
Last Update Posted : May 13, 2009
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 or disease||Intervention/treatment||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|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Role of Mosapride in Patients With Gastroesophageal Reflux Disease|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||May 2009|
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
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00729339
|Lotung Poh-Ai Hospital|
|Lotung Town, Ilan County, Taiwan, 265|
|Principal Investigator:||Hwai-Jeng Lin, M.D.||Lotung Poh-Ai Hospital|