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)
Overview
- Phase
- Phase 3
- Intervention
- UI05MSP015CT
- Conditions
- Functional Dyspepsia
- Sponsor
- Korea United Pharm. Inc.
- Enrollment
- 143
- Primary Endpoint
- Change of symptom score of functional dyspepsia
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
UI05MSP015CT
UI05MSP015CT and Placebo of Gasmotin
Intervention: UI05MSP015CT
Gasmotin
Placebo of UI05MSP015CT and Gasmotin
Intervention: Gasmotin
Outcomes
Primary Outcomes
Change of symptom score of functional dyspepsia
Time Frame: 4weeks
Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.
Secondary Outcomes
- Change of symptom score of functional dyspepsia(2weeks)
- NDI-K questionnaire(4weeks)
- General symptom improvement(2weeks, 4weeks)