Comparing ebastine and mebeverine for treating IBS
Multicenter Randomized Controlled Clinical Trial Comparing Ebastine and Mebeverine as Treatment of Irritable Bowel Syndrome
PHASE3 · KU Leuven · NCT05815602
This study is testing whether ebastine or mebeverine works better for treating abdominal pain in people with non-constipated irritable bowel syndrome (IBS).
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | KU Leuven (other) |
| Locations | 5 sites (Antwerp, Antwerpen and 4 other locations) |
| Trial ID | NCT05815602 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized controlled trial aims to compare the clinical efficacy of ebastine, a histamine 1 receptor antagonist, with mebeverine, a commonly used antispasmodic, in treating non-constipated irritable bowel syndrome (IBS). The study will evaluate the impact of both treatments on patients' quality of life and quality-adjusted life years. By focusing on patients who meet the Rome IV criteria for IBS, the trial seeks to provide evidence supporting ebastine as a potentially superior treatment option for abdominal pain associated with IBS.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 who have been diagnosed with non-constipated IBS and meet the Rome IV criteria.
Not a fit: Patients with IBS-C subtypes, serious comorbid conditions, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a more effective treatment option for patients suffering from non-constipated IBS.
How similar studies have performed: Other studies have shown promising results with histamine receptor antagonists in treating IBS, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. Patients fulfilling the Rome IV criteria for non-constipated IBS (IBS-C subtypes will be excluded) 3. No organic cause that can explain the presenting symptoms (exclusion of coeliac disease (blood), lactose intolerance (breath test), inflammatory bowel disease and giardiasis (stool) 4. Patients with lactose intolerance can be included if no improvement on lactose free diet during 6 weeks 5. Age 18-65 Exclusion Criteria: 1. 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, insuline-dependent diabetes, psychiatric diseases 2. Pregnancy, breast feeding 3. 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. 4. Symptoms started following abdominal surgery 5. IBS constipation dominant (IBS-C) 6. Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 of the SmPC of the respective medicinal products
Where this trial is running
Antwerp, Antwerpen and 4 other locations
- GZA — Antwerp, Antwerpen, Belgium (RECRUITING)
- UZA — Antwerp, Antwerpen, Belgium (RECRUITING)
- AZ St-Maarten — Mechelen, Antwerpen, Belgium (RECRUITING)
- UZLeuven — Leuven, Vlaams-Brabant, Belgium (RECRUITING)
- AZ St-Lucas — Bruges, West-Vlaanderen, Belgium (RECRUITING)
Study contacts
- Principal investigator: Guy Boeckxstaens, prof. dr. — KU Leuven
- Study coordinator: Koen Bellens, MSc.
- Email: koen.bellens@kuleuven.be
- Phone: +3216341943
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: IBS - Irritable Bowel Syndrome, IBS, ebastine, duspatalin, Irritable Bowel Syndrome