Irritable Bowel Syndrome With Diarrhea Clinical Trial
Official title:
Double-blind, Randomised, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Effect of Oral Ibodutant in 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 the neurokinin type 2 receptor antagonist Ibodutant in improving IBS-D symptoms.
The study evaluates the efficacy and safety of three doses of ibodutant, given once daily
for 8 weeks versus placebo in IBS-D patients. Efficacy is evaluated in terms of overall
symptom relief and abdominal pain/discomfort relief after 8 weeks of treatment. The clinical
phase of the study comprises a 2-week run-in period (treatment-free),an 8-week double-blind
treatment period and a 2-week treatment withdrawal period, resulting in a 10-week overall
duration of the study for each patient.
Patients report their IBS-related symptoms daily in an electronic diary (web-and telephone
based)during all periods of the study.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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