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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
143
UI05MSP015CT and Placebo of Gasmotin
Placebo of UI05MSP015CT and Gasmotin
Change of symptom score of functional dyspepsia
Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.
Time frame: 4weeks
Change of symptom score of functional dyspepsia
Change of symptom score of functional dyspepsia was evaluated by symptom-specific questionnaire.
Time frame: 2weeks
General symptom improvement
Selecting: 'loss of symptom', 'apparent improvement', 'moderate improvement', 'no change', and 'deterioration'.
Time frame: 2weeks, 4weeks
NDI-K questionnaire
25 questions on five quality of life areas
Time frame: 4weeks
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