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Compares treatment options for IBS - Irritable Bowel Syndrome
Official title Ebastine Versus Mebeverine in IBS Patients
ClinicalTrials.gov ID: NCT05815602
What this study is testing
What is Ebastine?
Ebastine is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for ibs - irritable bowel syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- Patients with lactose intolerance can be included if no improvement on lactose free diet during 6 weeks
- Age 18-65
You likely can't join if
- History of coeliac disease, food allergy, giardiasis, inflammatory bowel disease, infectious gastroenteritis, motility disorder, serious liver kidney...
- Pregnancy, breast feeding
- Medication: the use of antidepressants or antipsychotics, anti-allergic medication or drugs affecting gastrointestinal motility / visceral...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Antwerp, Antwerpen, Belgium
- Mechelen, Antwerpen, Belgium
- Leuven, Vlaams-Brabant, Belgium
- Bruges, West-Vlaanderen, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Antwerp, Antwerpen, Belgium; Mechelen, Antwerpen, Belgium; Leuven, Vlaams-Brabant, Belgium; Bruges, West-Vlaanderen, Belgium. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.