E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Irritable Bowel Syndrome. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023003 |
E.1.2 | Term | Irritable bowel syndrome |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
To assess the safety and tolerability of a 4-week oral MEN15596 treatment up to 60 mg once daily in IBS patients.
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).
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
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.
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E.4 | Principal exclusion criteria |
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. |
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E.5 End points |
E.5.1 | 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). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |