Trial | NCT00663897  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    329
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.
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 Started
May 31
2008
Primary Completion
Jul 31
2009
Study Completion
Sep 30
2009
Last Update
Oct 09
2009
Estimate

Drug lansoprazole

lansoprazole, 30 mg, once daily for 14 days

  • Other names: Takepron (brand name)

Drug mosapride

mosapride, 5 mg, thrice daily for 14 days

  • Other names: Mopride (brand name)

1 Experimental

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

2 Active Comparator

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

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
No Results Posted