Role of Mosapride in Patients With Gastroesophageal Reflux Disease

NCT00729339 | Completed Phase 4 DMC

• 1 other identifier: OMCP-97-011
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastroesophageal Reflux Disease

Keywords

Gastroesophageal reflux disease; Mosapride; Lansoprazole

Outcome Measures

Primary Outcomes (1)

• Symptom improvement evaluated by frequent scale for the symptoms of gastroesophageal reflux disease (FSSG)

  before enrollment, one month after treatment, two months after treatment

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

ACTIVE COMPARATOR

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

Interventions

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

1

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

2

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lotung Poh-Ai Hospital: lead
• Tomorrow Medical Foundation: collaborator

Study Sites (1)

Lotung Poh-Ai Hospital

Lotung Town, Ilan County, 265, Taiwan

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

mosapride

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Hwai-Jeng Lin, M.D.

  Lotung Poh-Ai Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 31, 2008
• First Posted: August 7, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 13, 2009

Record last verified: 2009-05

Locations

TW (1)