Skip to main content
OpenTrials
Completed

NCT Number: NCT00729339

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Gastroesophageal Reflux Disease Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Lotung Poh-Ai Hospital

Lotung Town, Ilan County, 265, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mosapride for the first month and placebo for the 2nd month

Drug

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

placebo for the first and mosapride for the second month

Drug

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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Lotung Poh-Ai Hospital

Other

Collaborators

  • Tomorrow Medical Foundation

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 7, 2008
Registry last updated
May 13, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.