Multicenter randomized controlled clinical trial comparing ebastine and mebeverine as treatment of irritable bowel syndrome
- Conditions
- Irritable Bowel SyndromeTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- CTIS2022-501780-41-00
- Lead Sponsor
- Z Leuven
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures, Patients fulfilling the Rome IV criteria for non-constipated IBS, No organic cause that can explain the presenting symptoms (exclusion of coeliac disease (blood), lactose intolerance (breath test), inflammatory bowel disease and giardiasis (stool), Patients with lactose intolerance can be included if no improvement on lactose free diet during 6 weeks, Age 18-65
History of coeliac disease, food allergy, giardiasis, inflammatory bowel disease, infectious gastroenteritis, motility disorder, serious liver kidney cardiac or pulmonary disease, known cardiac rhythm disorders, insulinedependent diabetes, psychiatric diseases, Pregnancy, breast feeding, Medication: the use of antidepressants or antipsychotics, anti-allergic medication or drugs affecting gastrointestinal motility / visceral sensitivity (anti-cholinergics, antispasmodics, 5-HT3 antagonists, 5-HT4 agonists, loperamide, codeine, laxatives, analgesics: only paracetamol is allowed as analgetic, other analgesics are forbidden.), CYP3A4-inducing and inhibiting drugs. Potent inhibitors of CYP3A4 include clarithromycin, erythromycin, diltiazem, itraconazole, ketoconazole, ritonavir, verapamil, goldenseal and grapefruit. Inducers of CYP3A4 include phenobarbital, phenytoin, rifampicin, St. John’s Wort and glucocorticoids., Symptoms started following abdominal surgery, IBS constipation dominant (IBS-C), Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC of the respective medicinal products and which are listed below: For ebastine: Ingredients: microkristallijne cellulose natriumzetmeelglycolaat (type A) watervrij ypromell silicium magnesiumstearaat Filmomhulling: ypromellose titaandioxide (E171) macrogol 400 For duspatalin: Ingredients: Magnesiumstearaat, polyacrylaat dispersie 30%, talk, hypromellose, copolymeer van methacrylzuur en ethylacrylaat (1:1) dispersie 30%, glyceroltriacetaat Omhulling van de capsule: Gelatine, titaandioxide (E171), drukinkt: schellak (E904), propyleenglycol, sterke ammoniaoplossing, kaliumhydroxide, zwart ijzeroxide (E172).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method