The purpose of the study is to evaluate the benefit of treatment with oral dose of Ibodutant (code: MEN 15596) on IBS symptoms and the safety and tolerability of this therapy.
Irritable Bowel Syndrome (IBS) is a functional disorder characterised by chronic or recurrent abdominal pain or discomfort associated with altered bowel habits. This trial aims to evaluate the efficacy of Ibodutant in improvement of IBS symptoms through a daily oral administration, testing three dosages or placebo in IBS patients for 4-weeks. In each patient, the experimental clinical phase encompasses a screening/ 2-week run-in period (no study medication), followed by a 4-weeks treatment period and a 2-weeks treatment withdrawal period, for total study duration of 8 weeks in each patient.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
554
Center for Clinical and Basic Research (CCBR)
Ballerup Municipality, Denmark
emovis GmbH
Berlin, Germany
Digestive Diseases Center "Gastro"
Riga, Latvia
Federal State Institution "Outpatient clinic #3" of President's Management Department of the Russian Federation
Moscow, Russia
Response of Overall IBS Symptom Relief - 50% Rule
Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?" Responder: report of satisfactory overall IBS symptom relief = "Yes" 2/4 weeks (50% rule)
Time frame: Four weeks
Response of Overall IBS Symptom Relief - 75% Rule
Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?" Responder: report of satisfactory overall IBS symptom relief = "Yes" 3/4 weeks (75% rule)
Time frame: Four weeks
Response of Overall IBS Symptom Relief in the Subgroup of Patients With IBS With Diarrhea (IBS-D) - 75% Rule
Weekly binary question (yes/no): "Did you have satisfactory relief of your overall IBS symptoms since the last visit?" Responder: report of satisfactory overall IBS symptom relief = "Yes" 3/4 weeks (75% rule)
Time frame: Four weeks
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Oral tablet matching the three dose levels of ibodutant, once daily
Academy of Medical Science of Ukraine
Dnipropetrovsk, Ukraine
Synexus Midlands Clinical Research Centre
Birmingham, United Kingdom