E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Irritable Bowel Syndrome (IBS) |
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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 demonstrate that Meteospasmyl relieves patients with IBS from their symptoms significantly better than a placebo, assessed on the magnitude of response observed on the pain/discomfort reported on a Visual Analogue Scale
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E.2.2 | Secondary objectives of the trial |
The rate of responses, changes in all symptoms, overall and over time, improvement in IBS life impact and safety issues are secondary objectives.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
For inclusion into the run-in period: • male or female ambulatory patients, aged 18-75 years • with IBS as defined by Rome III criteria: recurrent abdominal pain/discomfort at least 3 days per month in the 3 last months, with onset at least 6 months previously, associated with 2 or more of the following: • improvement with defecation • onset associated with a change in frequency of stool • onset associated with a change in form of stool • with a disease history < 5 years • able to adequately express IBS symptom complaints • able and willing to comply with study visits and procedures per protocol • having given a written informed consent • for women of childbearing potential, with adequate contraception For randomisation into the study: • Pain/discomfort frequency of at least 2 days a week during each of the 2 weeks of run-in period • Intensity of their pain /discomfort ≥ 60 mm on VAS at randomisation
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E.4 | Principal exclusion criteria |
• Functional bowel disorder other than IBS (FAPS, isolated constipation) • Clinical alert signs such as anaemia, rectorrhagia, unexplained weight loss, general health status deterioration • Underlying cause for symptomatology, which excludes IBS diagnosis (diabetes, thyroid dysfunction, bilio-pancreatic disorders, infectious diarrhoea…) • Gastro-intestinal cancer or significant gastro-intestinal surgical background • Any acute/uncontrolled systemic pathology • Liver function tests ≥ 3 times the upper normal limit • Known intolerance to Meteospasmyl® or one of its components • Regular use of Meteospasmyl within 6 months prior to inclusion • Use of antispasmodic, anti-diarrhoeal or laxatives; they must be stopped at inclusion, before entering the run-in period • Regular use of products able to interfere with study product evaluation. Anti-depressants must be taken at fixed dosage since three months prior to inclusion, anxiolytics must be taken at fixed dosage since one month prior to inclusion • Pregnant or breast-feeding women • Women of child-bearing potential without effective contraception (oral pill or intra-uterine device); if necessary a pregnancy test may be performed before entering the study • Patients likely to be non-compliant • Patients who have already been included in this study or who are participating in another study • Patients having received any other investigational agent within 3 months before randomisation • Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement of the pain/discomfort as assessed by the patient on a 100 mm Visual Analogical Scale (VAS), after 4 weeks of treatment. |
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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 | 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 | 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.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |