Ebastine Versus Mebeverine in IBS Patients

Phase 3

Recruiting

• Conditions: IBS - Irritable Bowel Syndrome; IBS

• Registration Number: NCT05815602
• Lead Sponsor: Guy Boeckxstaens

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-4-4
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Voluntary written informed consent of the participant or their legally authorized<br> representative has been obtained prior to any screening procedures<br><br> 2. Patients fulfilling the Rome IV criteria for non-constipated IBS (IBS-C subtypes<br> will be excluded)<br><br> 3. No organic cause that can explain the presenting symptoms (exclusion of coeliac<br> disease (blood), lactose intolerance (breath test), inflammatory bowel disease and<br> giardiasis (stool)<br><br> 4. Patients with lactose intolerance can be included if no improvement on lactose free<br> diet during 6 weeks<br><br> 5. Age 18-65<br><br>Exclusion Criteria:<br><br> 1. History of coeliac disease, food allergy, giardiasis, inflammatory bowel disease,<br> infectious gastroenteritis, motility disorder, serious liver kidney cardiac or<br> pulmonary disease, known cardiac rhythm disorders, insuline-dependent diabetes,<br> psychiatric diseases<br><br> 2. Pregnancy, breast feeding<br><br> 3. Medication: the use of antidepressants or antipsychotics, anti-allergic medication<br> or drugs affecting gastrointestinal motility / visceral sensitivity<br> (anti-cholinergics, antispasmodics, 5-HT3 antagonists, 5-HT4 agonists, loperamide,<br> codeine, laxatives, analgesics: only paracetamol is allowed as analgetic, other<br> analgesics are forbidden.), CYP3A4-inducing and inhibiting drugs. Potent inhibitors<br> of CYP3A4 include clarithromycin, erythromycin, diltiazem, itraconazole,<br> ketoconazole, ritonavir, verapamil, goldenseal and grapefruit. Inducers of CYP3A4<br> include phenobarbital, phenytoin, rifampicin, St. John's Wort and glucocorticoids.<br><br> 4. Symptoms started following abdominal surgery<br><br> 5. IBS constipation dominant (IBS-C)<br><br> 6. Hypersensitivity to the active substance or to any of the excipients listed in<br> section 6.1 of the SmPC of the respective medicinal products

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical Response to Abdominal Pain Intensity;Clinical Response to Global Relief of Symptoms