Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia

Study Overview
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Brief Summary
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This study is a multi-center, randomized, active-controlled, double-blind, non-inferiority, phase III clinical trial evaluating efficacy and safety of once-daily mosapride (UI05MSP015CT) in patients with functional dyspepsia.

Detailed Description
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Patients with functional dyspepsia were randomly assigned (1:1) to receive either UI05MSP015CT (15 mg once daily before breakfast, study group) or mosapride (5 mg three times a day before each meal, control group) and corresponding placebo t.i.d. or q.d. for 4 weeks.

Official Title
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Multi-center, Randomized, Active-Controlled, Double-Blind, Non-Inferiority, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of UI05MSP015CT in Functional Dyspepsia (MARS Study)

Conditions
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Functional Dyspepsia

Intervention / Treatment
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* Drug: UI05MSP015CT
* Drug: Gasmotin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age >19 years Diagnosis of functional dyspepsia meeting Rome III criteria At least three moderate or severe symptoms included in the Symptom Score No structural lesions of upper gastrointestinal tract Exclusion Criteria: History of dyspepsia unrelated to functional dyspepsia or diseases History of gastrointestinal surgery History of malignancy in the previous 5 years Psychiatric disorders including major depressive disorder and anxiety Liver cirrhosis or abnormal liver laboratory findings Advanced chronic kidney disease Uncontrolled hypertension Uncontrolled diabetes Pregnancy and lactation Recent history of taking medication affecting the gastrointestinal system

Ages Eligible for Study
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Minimum Age: 19 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UI05MSP015CT<br>UI05MSP015CT and Placebo of Gasmotin | Drug: UI05MSP015CT<br>* UI05MSP015CT and Placebo of Gasmotin<br>|
| Active Comparator: Gasmotin<br>Placebo of UI05MSP015CT and Gasmotin | Drug: Gasmotin<br>* Placebo of UI05MSP015CT and Gasmotin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of symptom score of functional dyspepsia | Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire. | 4weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of symptom score of functional dyspepsia | Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire. | 2weeks | 
| General symptom improvement | Selecting: 'loss of symptom', 'apparent improvement', 'moderate improvement', 'no change', and 'deterioration'. | 2weeks, 4weeks | 
| NDI-K questionnaire | 25 questions on five quality of life areas | 4weeks |