Lansoprazole Versus Mosapride for Functional Dyspepsia

Lotung Poh-Ai Hospital

Status and phase

Completed

Phase 4

Conditions

Functional Dyspepsia

Epigastric Pain Syndrome

Post Prandial Distress Syndrome

Treatments

Drug: lansoprazole

Drug: mosapride

Study type

Interventional

Funder types

Other

Identifiers

NCT00663897

OMCP-97-007

Details and patient eligibility

About

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.

Full 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.

Enrollment

329 patients

Sex

All

Ages

20 to 90 years old

Volunteers

No 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