Irritable Bowel Syndrome With Diarrhea Clinical Trial
Official title:
A 52-Week, Double-blind, Randomised, Placebo-controlled, Parallel-group Phase III Study With Re-randomisations at Week 25 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. This trial aims at 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 24-week treatment period
The study evaluates the efficacy and safety of ibodutant 10 mg, given once daily for 24
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 24 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 first
24-week double-blind treatment period, a second 26-week re-randomised treatment period
period and a 2-week safety follow-up, resulting in a maximum 58-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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