Ebastine Versus Mebeverine in IBS Patients

NCT05815602 | Recruiting Phase 3

• 1 other identifier: S67029
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

Brief Summary

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

1. 1.To perform a randomized superiority trial comparing the clinical efficacy of ebastine and mebeverine
2. 2.To evaluate the impact of treatment with ebastine compared to mebeverine on quality of life and quality-adjusted life years

Conditions

IBS - Irritable Bowel Syndrome; IBS

Keywords

ebastine; duspatalin; IBS; Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Ebastine verum and duspatalin placebo

EXPERIMENTAL

Drug: Ebastine

Duspatalin verum and ebastine placebo

ACTIVE COMPARATOR

Drug: Duspatalin

Interventions

Ebastine DRUG

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.

Ebastine verum and duspatalin placebo

Duspatalin DRUG

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.

Duspatalin verum and ebastine placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Patients with lactose intolerance can be included if no improvement on lactose free diet during 6 weeks
• Age 18-65

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy Boeckxstaens: lead
• Fund for Scientific Research, Flanders, Belgium: collaborator

Study Sites (5)

GZA

Antwerp, Antwerpen, 2000, Belgium

RECRUITING

UZA

Antwerp, Antwerpen, 2000, Belgium

RECRUITING

AZ St-Maarten

Mechelen, Antwerpen, 2800, Belgium

RECRUITING

UZLeuven

Leuven, Vlaams-Brabant, 3000, Belgium

RECRUITING

AZ St-Lucas

Bruges, West-Vlaanderen, 8310, Belgium

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

ebastine; mebeverine

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Guy Boeckxstaens, prof. dr.

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Koen Bellens, MSc.

CONTACT

+3216341943; koen.bellens@kuleuven.be

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: prof. dr.

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: April 18, 2023
• Study Start: March 30, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (5)