Multicenter randomized controlled clinical trial comparing ebastine and mebeverine as treatment of irritable bowel syndrome
Key facts
- Phase
- Phase 3
This trial has no sites in United States.
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Trial details
- Who runs it
- UZ Leuven
- Trial code
- EU 2022-501780-41-00
- Record updated
- 28 October 2026
- Original description
1. Perform a randomized superiority trial comparing the clinical efficacy of ebastine and mebeverine 2. Evaluate the impact of treatment with ebastine compared to mebeverine on quality of life and quality-adjusted life yearsRead full original descriptionShow less
1. Perform a randomized superiority trial comparing the clinical efficacy of ebastine and mebeverine 2. Evaluate the impact of treatment with ebastine compared to mebeverine on quality of life and quality-adjusted life years
Inclusion: 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.
Exclusion: Symptoms started following abdominal surgery; 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; 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; 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); Pregnancy, breast feeding; IBS constipation dominant (IBS-C).