Lansoprazole Versus Mosapride for Functional Dyspepsia

Study Overview
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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.

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.

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

Conditions
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Functional Dyspepsia, Epigastric Pain Syndrome, Post Prandial Distress Syndrome

Intervention / Treatment
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* Drug: lansoprazole
* Drug: mosapride


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Treatment with lansoprazole (30 mg) once daily for 14 days | Drug: lansoprazole<br>* lansoprazole, 30 mg, once daily for 14 days<br>* Other names: Takepron (brand name);|
| Active Comparator: 2<br>Treatment with mosapride (5 mg) thrice daily for 14 days | Drug: mosapride<br>* mosapride, 5 mg, thrice daily for 14 days<br>* Other names: Mopride (brand name);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of dyspeptic symptoms as evaluated by validated questionnaire |  | After 2-week treatment of lansoprazole or mosapride | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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functional dyspepsia, epigastric pain syndrome, postprandial distress syndrome, proton pump inhibitor, 5 HT-4 receptor agonist