Ebastine Versus Mebeverine in IBS Patients

Last updated: August 20, 2024
Sponsor: Guy Boeckxstaens
Overall Status: Active - Recruiting

Phase

3

Condition

Colic

Gastrointestinal Diseases And Disorders

Lactose Intolerance

Treatment

Duspatalin

Ebastine

Clinical Study ID

NCT05815602
S67029
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Voluntary written informed consent of the participant or their legally authorizedrepresentative has been obtained prior to any screening procedures

  2. Patients fulfilling the Rome IV criteria for non-constipated IBS (IBS-C subtypeswill be excluded)

  3. No organic cause that can explain the presenting symptoms (exclusion of coeliacdisease (blood), lactose intolerance (breath test), inflammatory bowel disease andgiardiasis (stool)

  4. Patients with lactose intolerance can be included if no improvement on lactose freediet during 6 weeks

  5. Age 18-65

Exclusion

Exclusion Criteria:

  1. History of coeliac disease, food allergy, giardiasis, inflammatory bowel disease,infectious gastroenteritis, motility disorder, serious liver kidney cardiac orpulmonary disease, known cardiac rhythm disorders, insuline-dependent diabetes,psychiatric diseases

  2. Pregnancy, breast feeding

  3. Medication: the use of antidepressants or antipsychotics, anti-allergic medicationor 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, otheranalgesics are forbidden.), CYP3A4-inducing and inhibiting drugs. Potent inhibitorsof CYP3A4 include clarithromycin, erythromycin, diltiazem, itraconazole,ketoconazole, ritonavir, verapamil, goldenseal and grapefruit. Inducers of CYP3A4include 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 insection 6.1 of the SmPC of the respective medicinal products

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Duspatalin
Phase: 3
Study Start date:
March 30, 2023
Estimated Completion Date:
January 01, 2028

Connect with a study center

  • AZ St-Maarten

    Mechelen, Antwerpen 2800
    Belgium

    Active - Recruiting

  • UZLeuven

    Leuven, Vlaams-Brabant 3000
    Belgium

    Active - Recruiting

  • AZ St-Lucas

    Brugge, West-Vlaanderen 8310
    Belgium

    Active - Recruiting

  • GZA

    Antwerpen, 2000
    Belgium

    Active - Recruiting

  • UZA

    Antwerpen, 2000
    Belgium

    Active - Recruiting

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