Role of Mosapride in Patients With Gastroesophageal Reflux Disease

Lotung Poh-Ai Hospital

Status and phase: Completed; Phase 4

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: placebo for the first and mosapride for the second month; Drug: mosapride for the first month and placebo for the 2nd month

Study type: Interventional

Funder types: Other

Identifiers

NCT00729339

OMCP-97-011

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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114 participants in 2 patient groups

1

Active Comparator group

Description:

lansoprazole plus mosapride for the first month, and followed by lansoprazole plus placebo for the second month

Treatment:

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

2

Active Comparator group

Description:

lansoprazole plus placebo for the first month, and lansoprazole plus mosapride for the second month

Treatment:

Drug: placebo for the first and mosapride for the second month