Ebastine Versus Mebeverine in IBS Patients

Recruitment & Eligibility

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

Study & Design

Arm && Interventions

Group	Intervention	Description
Ebastine verum and duspatalin placebo	Ebastine	-
Duspatalin verum and ebastine placebo	Duspatalin	-

Primary Outcome Measures

Name	Time	Method
Clinical Response to Global Relief of Symptoms	12 weeks of study medication administration	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.
Clinical Response to Abdominal Pain Intensity	12 weeks of study medication administration	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.

Secondary Outcome Measures

Name	Time	Method

Recruitment & Eligibility