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Ebastine Versus Mebeverine in IBS Patients

NCT05815602 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-03-23

No results posted yet for this 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

Conditions

  • IBS - Irritable Bowel Syndrome
  • IBS

Interventions

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.

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.

Sponsors & Collaborators

  • Fund for Scientific Research, Flanders, Belgium

    collaborator OTHER

  • Guy Boeckxstaens

    lead OTHER

Principal Investigators

  • Guy Boeckxstaens, prof. dr. · KU Leuven

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-30
Primary Completion
2027-10-01
Completion
2028-01-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05815602 on ClinicalTrials.gov