Efficacy and Safety of Meteospasmyl in Irritable Bowel Syndrome. a 4-week, multicentre, double-blind, randomised, placebo-controlled phase IV trial
- Conditions
- Irritable Bowel Syndrome (IBS)MedDRA version: 9.1Level: LLTClassification code 10023003Term: Irritable bowel syndrome
- Registration Number
- EUCTR2007-000060-25-HU
- Lead Sponsor
- aboratoires Mayoly Spindler SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 400
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
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
•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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 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<br>;Secondary Objective: The rate of responses, changes in all symptoms, overall and over time, improvement in IBS life impact and safety issues are secondary objectives.<br>;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.
- Secondary Outcome Measures
Name Time Method