E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 |
Confirm efficacy of otilonium bromide for symptom control (frequency of abdominal pain in patients with irritable bowel syndrome (IBS) in a superiority trial versus placebo. |
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E.2.2 | Secondary objectives of the trial |
- Definition of the pattern of pharmacological effects of otilonium bromide on the other IBS symptoms - Assessment of the impact of treatment with otilonium bromide on the patients’ quality of life - Evaluate whether a long term treatment with otilonium bromide can have long term effects on IBS symptoms, thereby retarding symptom relapse following treatment discontinuation - Evaluate the economic impact of the therapy - Evaluate the safety of treatments
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Positive diagnosis for IBS according to the following symptom-based criteria (Rome II): 12 weeks or more, which need not to be consecutive, in the last 12 months of abdominal pain/discomfort that has two of the following three features: (a) Relieved by defecation (b) Associated with a change in frequency of stool (c) Associated with a change in consistency of stool At least 2 episodes of abdominal pain for each week during the two weeks of run-in (at visit 2).
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E.4 | Principal exclusion criteria |
Pregnant and breast-feeding women Simultaneous participation in another clinical trial Inability to maintain the conditions of the trial Severe psychiatric disorders Severe neurological disorders Severe heart failure, severe ischemic heart disease and severe hypertension Lactose intolerance Any clinical condition capable of causing gastrointestinal malabsorption Previous intestinal surgery except appendicectomy History of organic gastro-intestinal disease, (e.g. inflammatory bowel disease, cancer, ectopic endometriosis) Parasitosis infection Bowel obstruction History of the following diseases in the previous 4 months: Clinically symptomatic severe anaemia Cholestasis Diabetes mellitus requiring treatment with oral antidiabetics or insulin Severe hepatic or renal functional abnormality according to investigator’s opinion Any chronic use (> 2 weeks continuously) in the previous month of concomitant medication that may affect gastro-intestinal motility and function and that cannot be stopped during the trial such as: anticholinergics, prokinetics, laxatives, antidiarrhoeals, analgesics, NSAIDs, opiates, antidepressants, probiotics and drugs adjusting the microbial state. An antithrombotic treatment with low dose of aspirin is permitted. Clinically relevant abnormal values in the laboratory tests Glaucoma Prostatic hypertrophy Pyloric stenosis Hypersensitivity to any ingredient of the study products (otilonium bromide and/or excipients).
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E.5 End points |
E.5.1 | Primary end point(s) |
Abdominal pain is the most frequent IBS symptom, and its frequency (independently of subjective perception of pain intensity) is easily assessable. Therefore the frequency of abdominal pain will be adopted as primary clinical endpoint. Our target will be its evaluation at the end of the treatment period versus baseline. Frequency of abdominal pain will be quantified by a 4-level score, based on the number of pain episodes:
0 = 0 to 1 episode during the week; this will be differentiated on the diary/CRF 1 = 2 to 3 episodes during the week 2 = 4 to 7 episodes during the week 3 = 8 or more episodes during the week.
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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 | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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 | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |