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NCT Number: NCT05815602

Ebastine Versus Mebeverine in IBS Patients

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

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Key information

Conditions

IBS - Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Digestive System Diseases Gastrointestinal Diseases IBS Intestinal Diseases Irritable Bowel Syndrome

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GZA, Antwerp, Antwerpen, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • No organic cause that can explain the presenting symptoms (exclusion of coeliac disease (blood), lactose intolerance (breath test), inflammatory bowel disease and giardiasis (stool)
  • Patients with lactose intolerance can be included if no improvement on lactose free diet during 6 weeks
  • Age 18-65

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Clinical Response to Abdominal Pain Intensity

    Time frame: 12 weeks of study medication administration

    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.

  2. Clinical Response to Global Relief of Symptoms

    Time frame: 12 weeks of study medication administration

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Koen Bellens, MSc.

CONTACT

[email protected]

+3216341943 ext. 41943

Sponsors and collaborators

Lead sponsor

Guy Boeckxstaens

Other

Collaborators

  • Fund for Scientific Research, Flanders, Belgium

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 18, 2023
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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