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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

July 31, 2008
May 12, 2009
June 2008
April 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00729339 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Role of Mosapride in Patients With Gastroesophageal Reflux Disease
Role of Mosapride in Patients With Gastroesophageal Reflux Disease

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Gastroesophageal Reflux Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
114
May 2009
April 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
NCT00729339
OMCP-97-011
Yes
Hsin-Hong Chen/Superintendent, Lotung Poh-Ai Hospital
Lotung Poh-Ai Hospital
Tomorrow Medical Foundation
Principal Investigator: Hwai-Jeng Lin, M.D. Lotung Poh-Ai Hospital
Lotung Poh-Ai Hospital
May 2009

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