Estudio doble ciego, aleatorizado, controlado con placebo, de grupos paralelos para evaluar los efectos de un tratamiento de 4 semanas con dosis orales de MEN15596 en el síndrome de colon irritable.Double blind, randomized, placebo-controlled, parallel group study to evaluate the effect of a 4-week treatment with oral doses of MEN15596 in irritable bowel syndrome. - Not applicable
- Conditions
- Irritable Bowel Syndrome.MedDRA version: 9.1Level: LLTClassification code 10023003Term: Irritable bowel syndrome
- Registration Number
- EUCTR2008-000214-71-ES
- Lead Sponsor
- aboratorios Menarini S.A. (Menarini Group)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 554
Patients meeting the following criteria will be eligible for entry into the study and start the run in period:
1. Mentally competent, able to give written informed consent prior to study entry and compliant to undergo all visits and procedures scheduled in the study.
2. Male or female patients aged 18 - 70 years.
3.Clinical diagnosis of IBS (all subtypes of IBS-d, IBS-c, IBS-m, or IBS-u) according to the following symptom-based criteria as per Rome III 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.
4. 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 the start of run-in period (Day -14).
5. Use of appropriate contraceptive methods 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 six months.
6. Normal physical examination or without clinically relevant abnormalities.
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
Patients meeting ANY of the following criteria will not be eligible to participate in the study:
1.IBS patients having more than 3 bowel movements/day (for more than 1 day/ week) OR less than 2 bowel movements/week during the 2 week run in period.
2. Patients with organic abnormalities of the gastro-intestinal tract, including history of colonic or major abdominal surgery, (appendicectomy or hysterectomy excluded), current or previous diagnosis of neoplasia, inflammatory bowel diseases, symptomatic gallbladder stone disease, diverticulosis/diverticulitis, ectopic endometriosis.
3. History of gluten enteropathy.
4. Lactose intolerance as assessed by response to diet.
5. Diagnosis of ova or parasites, or occult blood in the stool in the previous 6 months.
6. Previous diagnosis of Diabetes Mellitus (either type 1 or 2).
7. 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 from at least two months.
8. Major psychiatric, neurological or cardiovascular disorders.
9. Use of prohibited concurrent medication within 7 days prior to screening, namely:
- antimuscarinic drugs.
- analgesic drugs (opioid 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 six 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 six months.
- other medications for IBS. NOTE: short-term use of the antidiarrhoeal Loperamid and laxative Bisacodyl 7 days prior to screening is allowed in accordance with the use described under section 7.3.1 of the Protocol.
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 trials 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 Main Objective: To evaluate the efficacy of three doses of MEN 15596 on IBS symptoms relief as compared to placebo in the broad population of irritable bowel syndrome (IBS) patients following a 4 week oral treatment.;Secondary Objective: To assess the safety and tolerability of a 4-week oral MEN15596 treatment up to 60 mg once daily in IBS patients.<br><br>To evaluate the efficacy and safety and tolerability of MEN15596 in each subpopulation of IBS patients, namely diarrhoea-prevalent, constipation-prevalent, mix of both, and unsubtyped IBS (IBS-d, IBS-c, IBS-m, and IBS-u, respectively).<br><br>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.<br>;Primary end point(s): Response for relief of overall IBS symptoms (SGA), at the end of 4 weeks of treatment, where response is defined as at least two weeks with satisfactory relief during four week treatment (50% rule).
- Secondary Outcome Measures
Name Time Method