Irritable Bowel Syndrome (IBS) MedDRA version: 9.1 Level: LLT Classification code 10023003 Term: Irritable bowel syndrome
Conditions
Interventions
Trade Name: Meteospasmyl
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsule, soft
Route of administration of the placebo: Oral use
Sponsors
Laboratoires Mayoly Spindler SA
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ;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. ;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. | — |
Countries
Hungary
Outcome results
None listed