Ebastine Versus Mebeverine in IBS Patients

Study Overview
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Brief Summary
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Multicenter randomized controlled clinical trial comparing ebastine and mebeverine as treatment of irritable bowel syndrome Trial rationale To perform a randomized superiority trial comparing the clinical efficacy of ebastine and mebeverine To evaluate the impact of treatment with ebastine compared to mebeverine on quality of life and quality-adjusted life years Primary objective To provide further evidence of the superiority of histamine 1 receptor antagonism as novel treatment for patients with non-constipated IBS, as compared to mebeverine, one of the spasmolytics currently used as first line treatment of IBS. Secondary objective(s) To provide evidence that the histamine 1 receptor antagonist ebastine is more effective in reducing abdominal pain compared to the commonly used antispasmodic mebeverine

Official Title
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Multicenter Randomized Controlled Clinical Trial Comparing Ebastine and Mebeverine as Treatment of Irritable Bowel Syndrome

Conditions
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IBS, IBS - Irritable Bowel Syndrome

Intervention / Treatment
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* Drug: Ebastine
* Drug: Duspatalin


Participation Criteria
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Eligibility Criteria
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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 (IBS-C subtypes will be excluded) 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, insuline-dependent 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ebastine verum and duspatalin placebo<br> | Drug: Ebastine<br>* Randomized subjects will administer 4 pills of study medication per day during 12 weeks. Daily administration schedule consists of taking 2 pills in the morning (1 verum, and 1 placebo). In the evening, subjects will take a second dose of both verum and placebo.<br>|
| Active Comparator: Duspatalin verum and ebastine placebo<br> | Drug: Duspatalin<br>* Randomized subjects will administer 4 pills of study medication per day during 12 weeks. Daily administration schedule consists of taking 2 pills in the morning (1 verum, and 1 placebo). In the evening, subjects will take a second dose of both verum and placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Response to Abdominal Pain Intensity | The primary endpoint is defined as Clinical Response to Abdominal Pain Intensity and Global Relief of Symptoms. A clinical responder is defined to be a Weekly Responder for both Abdominal Pain Intensity and Global Relief of Symptoms for at least 3 out of the 6 last weeks of treatment. Abdominal Pain Intensity is assessed daily by the subject during the 14 days prior to (run-in) and following (run-out) randomization and for 12 weeks during treatment, using a 10-point scale. For each week during and following treatment, an average pain score is calculated. Then %change from the mean baseline will be calculated. An Abdominal Pain Intensity Weekly Responder is defined as a subject who had a decrease of >=30% compared with baseline. | 12 weeks of study medication administration | 
| Clinical Response to Global Relief of Symptoms | Global Relief of Symptoms is assessed on a weekly basis using a 7-point scale for 12 weeks during treatment and run-out: a Weekly Responder is defined if he has total or obvious relief of symptoms. | 12 weeks of study medication administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ebastine, duspatalin, IBS, Irritable Bowel Syndrome