It is a randomized double-blind parallel phase IV study to compare Fenoverine and Trimebutine maleate in the efficacy and safety. Study Hypothesis: Fenoverine is non-inferior to Trimebutine maleate in its efficacy and safety.
For subjects with IBS, Fenoverine and Trimebutine will be administered orally for 8 weeks; Fenoverine 100mg capsule three times a day and Trimebutine 150mg tablet three times a day. Because one is capsule and the other is tablet, double dummy design will be used. Efficacy is evaluated at the end of 8 weeks and safety will be followed for 4 more weeks after the end of the scheduled medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
186
Fenoverine 100mg three times a day for 8 weeks
Timebutine maleate 150mg three times a day for 8 weeks
Korea University Ansan Hospital
Ansan, South Korea
Hallym University Sacred Heart Hospital
Anyang, South Korea
Kangwon National University Hospital
Chuncheon, South Korea
Gachon University Gil Hospital
Incheon, South Korea
the proportion of subjects with improvement in abdominal pain or discomfort
the proportion of subjects who experienced more than 30% improvement in abdominal pain or discomfort score with visual analog scale at week 8 compared to baseline
Time frame: week 8
BSS scores (each and total)
BSS score will be checked for four IBS symptoms; abdominal pain or discomfort, bloating, constipation, diarrhea. The scores will be compared for its chronological changes between trial groups. Total BSS score will be the sum of the scores of four symptoms measured.
Time frame: week 4, 8
overall BSS score
IBS symptom will be assessed overally by subjects at day 1, week 4, and week 8. The scores will be compared chronologically between groups.
Time frame: Week 4, 8
subject's satisfaction with treatment
Subject's satisfaction with the treatment is measured using visual analog scale.
Time frame: week 4, 8
adverse event
Vital signs will be checked at each visit. Laboratory tests will be conducted at baseline and week 8, and at any time if necessary.
Time frame: at each visit or contact until 4 weeks after the last dose
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Inje University Seoul Paik Hospital
Seoul, South Korea
Korea University Anam Hospital
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea