Lansoprazole Versus Mosapride for Functional Dyspepsia

Sponsor

Lotung Poh-Ai Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00663897

Collaborator

Tomorrow Medical Foundation (Other)

329

Enrollment

Location

Arms

Duration (Months)

20.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Functional dyspepsia is a common symptom complex with significant impact on quality of life. There is no standard treatment for functional dyspepsia but therapeutic efficacy of proton pump inhibitor (PPI) and prokinetic agent have been proved in subsets of patients. This study has two aims:

first is to compare the therapeutic efficacy of lansoprazole (a PPI) and mosapride (a prokinetic agent) for functional dyspepsia
second is to investigate whether different subgroups of functional dyspepsia (e.g., epigastric pain syndrome and postprandial distress syndrome) respond differently to PPI and prokinetic agent.

Condition or Disease	Intervention/Treatment	Phase
Functional Dyspepsia Epigastric Pain Syndrome Post Prandial Distress Syndrome	Drug: lansoprazole Drug: mosapride	Phase 4

Detailed Description

Eligible outpatients with presentation of dyspepsia are enrolled if they fulfilled the criteria of ROME III criteria. A trained assistant helps the eligible patients to complete the ROME III standard questionaire, brief symptom rating scale (BSRS), and Maudsley Personality Inventory (MPI). The enrolled patients are then randomized into either lansoprazole or mosapride group for 14-day treatment. Before starting medication, right after completing the medication, and 1 month after the medication, the enrolled patients complete standardized severity questionnaire (Hong-Kong Index) to evaluate severity of dyspeptic symptoms. Symptom improvement is then determined.

Study Design

Study Type:

Interventional

Actual Enrollment :

329 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Comparative Study of Lansoprazole and Mosapride for Functional Dyspepsia: Focus on Difference Between Epigastric Pain Syndrome and Postprandial Distress Syndrome

Study Start Date :

May 1, 2008

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Treatment with lansoprazole (30 mg) once daily for 14 days	Drug: lansoprazole lansoprazole, 30 mg, once daily for 14 days Other Names: Takepron (brand name)
Active Comparator: 2 Treatment with mosapride (5 mg) thrice daily for 14 days	Drug: mosapride mosapride, 5 mg, thrice daily for 14 days Other Names: Mopride (brand name)

Arm

Intervention/Treatment

Experimental: 1

Treatment with lansoprazole (30 mg) once daily for 14 days

Drug: lansoprazole

lansoprazole, 30 mg, once daily for 14 days

Other Names:

Takepron (brand name)

Active Comparator: 2

Treatment with mosapride (5 mg) thrice daily for 14 days

Drug: mosapride

mosapride, 5 mg, thrice daily for 14 days

Other Names:

Mopride (brand name)

Outcome Measures

Primary Outcome Measures

Improvement of dyspeptic symptoms as evaluated by validated questionnaire [After 2-week treatment of lansoprazole or mosapride]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

aged more than 20 years old
diagnosis of functional dyspepsia by fulfilling Rome-III criteria
outpatient

Exclusion Criteria:

aged less than 20 years
organic lesions including ulcers, tumors, bleeding, vasculopathy or esophagitis as demonstrated on upper endoscopy
concurrent illness with malignancy, diabetes mellitus, liver cirrhosis, renal failure or porphyria
diagnosis of organic disease for dyspeptic symptoms by treating physicians
history of abdominal surgery
concurrent user of aspirin and NSAID
history of allergy or severe side effects to lansoprazole or mosapride
pregnant or lactating women