Ebastine Versus Mebeverine in IBS Patients

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

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

Trial rationale

1. To perform a randomized superiority trial comparing the clinical efficacy of ebastine and mebeverine
2. 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

Study Overview

• Status: Recruiting
• Conditions: IBS - Irritable Bowel Syndrome; IBS
• Intervention / Treatment: Drug: Ebastine; Drug: Duspatalin

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Koen Bellens, MSc.; Phone Number: 41943 +3216341943; Email: koen.bellens@kuleuven.be

Study Locations

• Belgium
  • Antwerpen, Belgium, 2000
    • Recruiting
    • GZA
    • Contact: Sara Nullens; Phone Number: +3232852000; Email: sara.nullens@gza.be
    • Principal Investigator: Sara Nullens
  • Antwerpen, Belgium, 2000
    • Recruiting
    • UZA
    • Contact: Eveline Vanhaesebrouck; Phone Number: +3238214491; Email: Eveline.Vanhaesebrouck@uza.be
    • Principal Investigator: Heiko De Schepper
  • Antwerpen
    • Mechelen, Antwerpen, Belgium, 2800
      • Recruiting
      • AZ St-Maarten
      • Contact: Inez Mestdagh; Phone Number: +3215891664; Email: Inez.Mestdagh@Emmaus.be
      • Principal Investigator: Jurgen Van Dongen
  • Vlaams-Brabant
    • Leuven, Vlaams-Brabant, Belgium, 3000
      • Recruiting
      • UZLeuven
      • Principal Investigator: Guy Boeckxstaens, prof. dr.
      • Contact: Koen Bellens, MSc.; Phone Number: +3216341943; Email: koen.bellens@kuleuven.be
  • West-Vlaanderen
    • Brugge, West-Vlaanderen, Belgium, 8310
      • Recruiting
      • AZ St-Lucas
      • Contact: Mary Glorieux; Phone Number: +3250365711; Email: clinical.trials@stlucas.be
      • Principal Investigator: Joris Arts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ebastine verum and duspatalin placebo	Drug: Ebastine; 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.
Active Comparator: Duspatalin verum and ebastine placebo	Drug: Duspatalin; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Guy Boeckxstaens
• Collaborators: Fund for Scientific Research, Flanders, Belgium
• Investigators: Principal Investigator: Guy Boeckxstaens, prof. dr., KU Leuven

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Anticipated): October 1, 2026
• Study Completion (Anticipated): January 1, 2027

Study Registration Dates

• First Submitted: April 4, 2023
• First Submitted That Met QC Criteria: April 4, 2023
• First Posted (Actual): April 18, 2023

Study Record Updates

• Last Update Posted (Actual): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 10, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; IBS; ebastine; duspatalin
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Anticonvulsants; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Ebastine; Mebeverine
• Other Study ID Numbers: S67029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No