Gastroesophageal Reflux Disease
Conditions
Keywords
Gastroesophageal reflux disease, Mosapride, Lansoprazole
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.
Interventions
DRUGmosapride 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
DRUGplacebo 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
Sponsors
Tomorrow Medical Foundation
Lotung Poh-Ai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG) | before enrollment, one month after treatment, two months after treatment |
Countries
Taiwan
Outcome results
None listed