Ebastine Versus Mebeverine in IBS Patients

Sponsor
Guy Boeckxstaens
Study ID
NCT05815602
Phase
PHASE3
Status
Recruiting
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Conditions

  • IBS
  • IBS - Irritable Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

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.
  • 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.

Study Details

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

Key Dates

Start date
Mar 30, 2023
Status verified
Mar 2026
Primary completion
Oct 1, 2027
Completion
Jan 1, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ebastine verum and duspatalin placebo
  • Active Comparator: Duspatalin verum and ebastine placebo

Primary Outcome Measure

Clinical Response to Abdominal Pain Intensity [ Time Frame: 12 weeks of study medication administration ]

Central Contacts

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