NCT00663897

Lansoprazole Versus Mosapride for Functional Dyspepsia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 329 (actual)
• Sponsor: Lotung Poh-Ai Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Functional Dyspepsia
• Epigastric Pain Syndrome
• Post Prandial Distress Syndrome

Interventions

Type	Name	Description
DRUG	lansoprazole	lansoprazole, 30 mg, once daily for 14 days
DRUG	mosapride	mosapride, 5 mg, thrice daily for 14 days

Timeline

• Start date: 2008-05-01
• Primary completion: 2009-07-01
• Completion: 2009-09-01
• First posted: 2008-04-22
• Last updated: 2009-10-09

Locations

1 site across 1 country: Taiwan