Multicenter randomized controlled clinical trial comparing ebastine and mebeverine as treatment of irritable bowel syndrome

Z Leuven0 sites200 target enrollmentDecember 14, 2022

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Z Leuven
Enrollment: 200
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

December 14, 2022

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Z Leuven

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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\).