Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2023-03-30
2028-01-01
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ebastine verum and duspatalin placebo
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.
Duspatalin verum and ebastine placebo
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
65 Years
ALL
No
Sponsors
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Fund for Scientific Research, Flanders, Belgium
OTHER
Guy Boeckxstaens
OTHER
Responsible Party
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Guy Boeckxstaens
prof. dr.
Principal Investigators
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Guy Boeckxstaens, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Locations
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AZ St-Maarten
Mechelen, Antwerpen, Belgium
UZLeuven
Leuven, Vlaams-Brabant, Belgium
AZ St-Lucas
Bruges, West-Vlaanderen, Belgium
GZA
Antwerp, , Belgium
UZA
Antwerp, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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S67029
Identifier Type: -
Identifier Source: org_study_id
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