Lansoprazole Versus Mosapride for Functional Dyspepsia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

329 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-09-30

Brief Summary

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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.

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Detailed Description

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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

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Functional Dyspepsia Epigastric Pain Syndrome Post Prandial Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type EXPERIMENTAL

lansoprazole

Intervention Type DRUG

lansoprazole, 30 mg, once daily for 14 days

2

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

Group Type ACTIVE_COMPARATOR

mosapride

Intervention Type DRUG

mosapride, 5 mg, thrice daily for 14 days

Interventions

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lansoprazole

lansoprazole, 30 mg, once daily for 14 days

Intervention Type DRUG

mosapride

mosapride, 5 mg, thrice daily for 14 days

Intervention Type DRUG

Other Intervention Names

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Takepron (brand name) Mopride (brand name)

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No