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Multicenter randomized controlled clinical trial comparing ebastine and mebeverine as treatment of irritable bowel syndrome

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-501780-41-00
Enrollment
200
Registered
2023-03-28
Start date
2023-05-17
Completion date
Unknown
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Irritable Bowel Syndrome

Brief summary

Abdominal Pain Intensity, Global Relief of Symptoms

Detailed description

Overall Response (Abdominal Pain Intensity & Global Relief of Symptoms): Weekly Responder for >= 6 weeks during the 12 weeks of treatment, Weekly Response up to Week 12, Weekly Response during Run-Out Period, Clinical Abdominal Pain Intensity Response: Abdominal Pain Intensity Weekly Responder for >= 3 weeks during the last 6 weeks of treatment, Overall Abdominal Pain Intensity Response: Abdominal Pain Intensity Weekly Responder for >= 6 weeks during the 12 weeks of treatment, Abdominal Pain Intensity Weekly Response up to Week 12, Weekly average Abdominal Pain Intensity Scores up to Week 12, %Change in weekly average Abdominal Pain Intensity Scores up to Week 12, Weekly average Abdominal Pain Intensity Scores during Run-Out period, Clinical Global Symptom Relief response: weekly responder for >= 3 weeks during the last 6 weeks of treatment, Overall Global Symptom Relief response: weekly responder for >= 6 weeks during the 12 weeks of treatment, Weekly Global Symptom Relief Response up to Week 12, Weekly Global Symptom Relief during Run-Out Period, Overall Stool Consistency Response: Stool Consistency Weekly responder for >= 6 weeks, Clinical Stool Consistency response: Stool Consistency Weekly Responder for >=3 weeks during the last 6 weeks of treatment, Stool Consistency Weekly Response up to Week 12, Weekly number of days with at least 1 stool of consistency 6 or 7 up to Week 12, Weekly number of days with at least 1 stool of consistency 6 or 7 during Run-Out Period, %Change in weekly number of days with at least 1 stool of consistency 6 or 7 up to Week 12, IBS-SSS score: score between 0 and 500 assessed at baseline and at 12 weeks; IBS-SSS Score and change in score at 12 weeks; IBS-SSS response: decrease >= 50 points, Quality of Life at Week 12

Interventions

DRUGEbastine-dummy.
DRUGDuspatalin Retard 200 mg capsules met verlengde afgifte
DRUGhard
DRUGEBASTINE TEVA 20 mg FILMTABLETTEN
DRUGDuspatalin-dummy

Sponsors

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Abdominal Pain Intensity, Global Relief of Symptoms

Secondary

MeasureTime frame
Overall Response (Abdominal Pain Intensity & Global Relief of Symptoms): Weekly Responder for >= 6 weeks during the 12 weeks of treatment, Weekly Response up to Week 12, Weekly Response during Run-Out Period, Clinical Abdominal Pain Intensity Response: Abdominal Pain Intensity Weekly Responder for >= 3 weeks during the last 6 weeks of treatment, Overall Abdominal Pain Intensity Response: Abdominal Pain Intensity Weekly Responder for >= 6 weeks during the 12 weeks of treatment, Abdominal Pain Intensity Weekly Response up to Week 12, Weekly average Abdominal Pain Intensity Scores up to Week 12, %Change in weekly average Abdominal Pain Intensity Scores up to Week 12, Weekly average Abdominal Pain Intensity Scores during Run-Out period, Clinical Global Symptom Relief response: weekly responder for >= 3 weeks during the last 6 weeks of treatment, Overall Global Symptom Relief response: weekly responder for >= 6 weeks during the 12 weeks of treatment, Weekly Global Symptom Relief Response up

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026