Irritable bowel syndrome with diarrhoea (IBS-D) MedDRA version: 14.0 Level: LLT Classification code 10060849 Term: Diarrhoea predominant irritable bowel syndrome System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Ibodutant
Pharmaceutical Form: Tablet
Current Sponsor code: Ibodutant
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the pl
Sponsors
Menarini Ricerche S.p.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting the following criteria will be eligible for entry into the study and start the run-in period: 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 year and after the onset of IBS symptoms, and completed before Screening (Day -14). 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 75% of the nominal daily entry expected during both weeks of the run-in period). • No use of prohibited concurrent medication. NOTE: No short-term use of the antidiarrhoeal loperamide is allowed during the run-in period. • No clinically relevant abnormalities in laboratory findings and/or 12-lead ECG performed at Screening. 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
Exclusion criteria
Exclusion criteria: Patients will not be eligible to participate in the study if they meet ANY of the following exclusion criteria: 1. Organic abnormalities of the 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. The absence of gluten entropathy has to be documented by negative IgA antibodie against tissue transglutaminase and endomysium indentified within the last 24 months 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 antidepressants is only allowed when the drug type and its dose regimen has 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 has not been changed in the previous 6 months. - Other medication 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of 3 oral doses of ibodutant on IBS symptoms relief and abdominal pain/discomfort relief as compared to placebo in IBS-D patients following an 8-week oral treatment course.;Secondary Objective: • To assess the safety and tolerability of an 8-week oral ibodutant treatment up to 10 mg once daily in IBS-D patients. • To make an overall assessment of efficacy and tolerability in order to select the dose to be tested in the subsequent phase III clinical development. ;Primary end point(s): 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) (weekly IVRS/IWRS diary records). | — |
Countries
Bulgaria, Czech Republic, Denmark, Germany, Italy, Spain, Sweden
Outcome results
None listed