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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
565
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 6 Weeks With Satisfactory Relief During 8 Weeks of Treatment (75% Rule); Intention-to-treat (ITT).
Weekly binary questions (yes/no) from Interactive Voice/Web Response (IV/WRS) diary records: "Did you have satisfactory relief of your overall IBS symptoms during the last week?" and "Did you have satisfactory relief of your abdominal pain or discomfort during the last week?" Responder: Report of satisfactory overall IBS symptom relief ="Yes" and of satisfactory abdominal pain/discomfort relief = "Yes" 6/8 weeks (75% rule)
Time frame: Eight weeks
Response for Relief of Overall IBS Symptoms and of Abdominal Pain/Discomfort at the End of 8 Weeks of Treatment, Where the Response is Defined as at Least 4 Weeks With Satisfactory Relief During 8 Weeks of Treatment (50% Rule) in the ITT Population
Weekly binary questions (yes/no) from IV/WRS diary records: "Did you have satisfactory relief of your overall IBS symptoms during the last week?" and "Did you have satisfactory relief of your abdominal pain or discomfort during the last week?" Responder: Report of satisfactory overall IBS symptom relief ="Yes" and of satisfactory abdominal pain/discomfort relief = "Yes" 4/8 weeks with at least 2 consecutive weeks of satisfactory relief during Week 5 to Week 8(50% rule)
Time frame: Eight weeks
Quality of Life Changes (Using EuroQoL EQ-5D Questionnaire)
Change in EQ-5D Quality of Life (visual analogue scale) score at the end of 8 weeks of treatment versus baseline (at randomisation). EQ-5D quality of life visual analogue scale ranges from "0"= worst imaginable health state to "100"=best imaginable health state.
Time frame: Eight weeks
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Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks
MHAT "Haskovo", Second Internal Department
Haskovo, Bulgaria
UMHAT "Dr. Georgi Stranski", Clinic of Gastroenterology
Pleven, Bulgaria
MHAT "Kaspela", Department of Gastroenterology
Plovdiv, Bulgaria
UMHAT "Sveti Georgi", Internal Consultative Department
Plovdiv, Bulgaria
MHAT "Ruse", Clinic of Gastroenterology
Rousse, Bulgaria
Fifth City Hospital, Gastroenterology Department
Sofia, Bulgaria
UMHAT "Alexandrovska", Clinic of Propedeutic of Internal Disease
Sofia, Bulgaria
MHAT "Sveta Anna", Department of Gastroenterology, Endocrinology, and Nephrology
Sofia, Bulgaria
UMHAT "St. Marina", Clinic of Gastroenterology
Varna, Bulgaria
MHAT "Dr. Stefan Cherkezov", Gastroenterology Department
Veliko Tarnovo, Bulgaria
...and 61 more locations