Irritable Bowel Syndrome With Diarrhea Clinical Trial
Official title:
A 12-week Double-blind, Randomised, Placebo-controlled, Parallel Group Phase III Study, Followed by a 4-week Randomised Withdrawal Period to Evaluate the Efficacy and Safety of Oral Ibodutant 10 mg Once Daily in Female Patients With Irritable Bowel Syndrome With Diarrhoea (IBS-D).
Irritable Bowel Syndrome with diarrhoea (IBS-D) is a functional gastrointestinal disorder characterised by chronic or recurrent abdominal pain or discomfort and diarrhoea. The aim of this trial is the evaluation of the efficacy and safety of oral ibodutant 10 mg once daily as compared to placebo in women with IBS-D over a 12-week treatment period.
The study evaluates the efficacy and safety of ibodutant 10 mg, given once daily for 12
weeks in comparison with placebo in female IBS-D patients. Randomisation to ibodutant and
placebo will be 1:1. Efficacy is evaluated in terms of weekly response for abdominal pain
intensity and stool consistency over 12 weeks of treatment in at least 50% of the weeks of
treatment.
The clinical phase of the study comprises up to 2 weeks of screening for patient's
eligibility, a 2-week run-in period (treatment-free) for IBS severity assessment, a 12-week
double-blind treatment period, a 4-week randomised withdrawal (RW) period and a 2-week
safety follow-up, resulting in a maximum 22-week overall duration of the study for each
patient.
Patients report their IBS-related symptoms daily in a telephone-based electronic diary from
run-in until end of treatment.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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