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). - IRIS-2
- Conditions
- Irritable bowel syndrome with diarrhoea (IBS-D).MedDRA version: 12.1Level: LLTClassification code 10060845Term: Diarrhea predominant irritable bowel syndrome
- Registration Number
- EUCTR2010-018300-85-IT
- Lead Sponsor
- MENARINI RICERCHE S.P.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 900
1 Male or female patients aged 18 - 70 years with a clinical diagnosis of IBS-D according to the following symptom-based criteria as per Rome III modular questionnaire criteria: - Recurrent abdominal pain or discomfort for at least 3 days per month in the last 3 months associated with at least 2 of the following characteristics: a) improvement with defecation; b) onset associated with a change in the frequency of stool; c) onset associated with a change in form (appearance) of stool. - Symptom-onset at least 6 months prior to diagnosis. - Loose or watery stools at least 25% of the time in the last 3 months AND hard or lumpy stools less than 25% of the time in the last 3 months. - Additional criterion: More than 3 bowel movements per day at least 25% of the time in the last 3 months. 2 For patients older than 50 years OR patients with positive family history of colorectal cancer: Normal results from colonoscopy or flexible sigmoidoscopy performed within the last 5 years and after the onset of IBS symptoms, and completed before Screening. 3 Mentally competent, able to give written informed consent prior to study entry and compliant to undergo all visits and procedures scheduled in the study. 4 For women of childbearing potential: Use of a highly effective contraceptive method with a failure rate <1% per year throughout the entire study period and up to 30 days post-treatment. Oral contraceptives are allowed provided that they have not been changed in the previous 6 months. 5 Normal physical examination or without clinically relevant abnormalities. Additional inclusion criteria at randomization (after a 2-week treatment-free run-in period with symptom collection by IVRS/IWRS diary) 1. Patients’ diary records during the run-in period showing: - at least 25% of the bowel movements with loose or watery (Bristol Stool Scale 6 or 7) consistency AND less than 25% of bowel movements with hard or lumpy (Bristol Stool Scale 1 or 2) consistency, - at least one bowel movement on each day, - weekly average of at least 3 bowel movements per day (during both weeks of the run-in period), - abdominal pain/discomfort of at least moderate (grade 2) severity at least 3 days per week (during both weeks of the run-in period). 2. Adequate compliance with the IVRS/IWRS diary recording procedure (> 75% of the nominal daily entry expected during both weeks of the run-in period). 3. No use of prohibited concurrent medication. NOTE: No short-term use of the antidiarrhoeal loperamide is allowed during the run-in period. 4. No clinically relevant abnormalities in laboratory findings and/or 12-lead ECG performed at Screening (Visit 1).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1 Organic abnormalities of the gastrointestinal (GI) tract, including history of colonic or major abdominal surgery, i.e. stomach, small/large bowel or large vessel abdominal surgery, (except appendicectomy, hysterectomy cholecystectomy, caesarean section, or laparoscopic surgery), current or previous diagnosis of neoplasia (except non-GI neoplasia in complete remission = 5 years), inflammatory bowel diseases, symptomatic gallbladder stone disease, complicated diverticulosis (i.e. diverticulitis), ectopic endometriosis. NOTE: Patients with alarm signs (e.g. fever, rectal bleeding, unintentional weight loss, anaemia) deserve special consideration to exclude any organic GI disease. 2 History of gluten enteropathy. 3 Lactose intolerance as assessed by response to diet. 4 History of positive tests for ova or parasites, or occult blood in the stool in the previous 6 months. 5 Previous diagnosis of diabetes mellitus (either type 1 or 2). 6 Unstable medical condition; i.e. patients for which concurrent diseases may compromise the efficacy and safety assessments as required in the study AND/OR require change in concomitant medication. NOTE: Thyroid hormone replacement therapy should be stable for at least the last 2 months. 7 Major psychiatric, neurological, or cardiovascular disorders, or uncontrolled metabolic disease. 8 Relevant changes in dietary habits, lifestyle, or exercise regimen in the previous 2 months. NOTE: dietary habits, lifestyle and exercise regimen must be maintained for the duration of the study 9 Use of prohibited concurrent medication within 7 days prior to Screening, namely: - Antimuscarinic drugs. - Drugs enhancing GI motility such as prokinetic drugs (e.g. metoclopramide, cisapride, domperidone) or laxatives. - Analgesic drugs (opioids or non-steroidal anti-inflammatory drugs). NOTE: Short term use of paracetamol is allowed for max 2 consecutive days. - Antidepressants. NOTE: The use of a single antidepressant is only allowed when the drug type and its dose regimen have not been changed in the previous 6 months. - Benzodiazepines. NOTE: The use of a single benzodiazepine is only allowed when it is administered as sleep-inducer and the drug type and its dose regimen have not been changed in the previous 6 months. - Other medications for IBS. NOTE: The antidiarrhoeal loperamide must be discontinued 3 days prior to Screening. 10 Pregnancy or breastfeeding. 11 Hypersensitivity to the drug excipients. 12 Patients not able to understand or collaborate throughout the study. 13 Participation in other clinical studies in the previous 4 weeks.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method