Lansoprazole Versus Mosapride for Functional Dyspepsia

Condition(s) targeted: Functional Dyspepsia; Epigastric Pain Syndrome; Post Prandial Distress Syndrome

Intervention: lansoprazole (Drug); mosapride (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Lotung Poh-Ai Hospital

Official(s) and/or principal investigator(s):
Yao-Chun Hsu, M.D., Principal Investigator, Affiliation: Lotung Poh-Ai hospital, I-Lan County, Taiwan

Overall contact:
Yao-Chun Hsu, M.D., Phone: 886-3-950-9579, Email: holdenhsu@ntu.edu.tw

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, and 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.

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Improvement of dyspeptic symptoms as evaluated by validated questionnaire

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.

Minimum age: 20 Years. Maximum age: 90 Years. Gender(s): Both.

Criteria:

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.

Yao-Chun Hsu, M.D., Phone: 886-3-950-9579, Email: holdenhsu@ntu.edu.tw

Lotung Poh-Ai hospital, Lotung Town, Ilan county 26546, Taiwan; Recruiting
Yao-Chun Hsu, M.D., Phone: 886-3-950-9579, Email: holdenhsu@ntu.edu.tw
Yao-Chun Hsu, M.D., Principal Investigator

The homepage of ROME foundation, an non-for-profit organization dedicated to scientific research and education information of functional gastrointestinal disorders (FGIDs).

Starting date: May 2008
Ending date: May 2009
Last updated: January 29, 2009