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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

UZ Leuven

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

17 May 2023 → ongoing

Decision date (initial)

2023-03-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

FWO - Fonds Wetenschappelijk Onderzoek

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

1. Perform a randomized superiority trial comparing the clinical efficacy of ebastine and mebeverine
2. Evaluate the impact of treatment with ebastine compared to mebeverine on quality of life and quality-adjusted life years

Conditions and MedDRA coding

Irritable Bowel Syndrome

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
2. Patients fulfilling the Rome IV criteria for non-constipated IBS
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 6

1. 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, insulinedependent diabetes, psychiatric diseases
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 and which are listed below: For ebastine: Ingredients: microkristallijne cellulose natriumzetmeelglycolaat (type A) watervrij ypromell silicium magnesiumstearaat Filmomhulling: ypromellose titaandioxide (E171) macrogol 400 For duspatalin: Ingredients: Magnesiumstearaat, polyacrylaat dispersie 30%, talk, hypromellose, copolymeer van methacrylzuur en ethylacrylaat (1:1) dispersie 30%, glyceroltriacetaat Omhulling van de capsule: Gelatine, titaandioxide (E171), drukinkt: schellak (E904), propyleenglycol, sterke ammoniaoplossing, kaliumhydroxide, zwart ijzeroxide (E172).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Abdominal Pain Intensity
2. Global Relief of Symptoms

Secondary endpoints 21

1. Overall Response (Abdominal Pain Intensity & Global Relief of Symptoms): Weekly Responder for >= 6 weeks during the 12 weeks of treatment
2. Weekly Response up to Week 12
3. Weekly Response during Run-Out Period
4. Clinical Abdominal Pain Intensity Response: Abdominal Pain Intensity Weekly Responder for >= 3 weeks during the last 6 weeks of treatment
5. Overall Abdominal Pain Intensity Response: Abdominal Pain Intensity Weekly Responder for >= 6 weeks during the 12 weeks of treatment
6. Abdominal Pain Intensity Weekly Response up to Week 12
7. Weekly average Abdominal Pain Intensity Scores up to Week 12
8. %Change in weekly average Abdominal Pain Intensity Scores up to Week 12
9. Weekly average Abdominal Pain Intensity Scores during Run-Out period
10. Clinical Global Symptom Relief response: weekly responder for >= 3 weeks during the last 6 weeks of treatment
11. Overall Global Symptom Relief response: weekly responder for >= 6 weeks during the 12 weeks of treatment
12. Weekly Global Symptom Relief Response up to Week 12
13. Weekly Global Symptom Relief during Run-Out Period
14. Overall Stool Consistency Response: Stool Consistency Weekly responder for >= 6 weeks
15. Clinical Stool Consistency response: Stool Consistency Weekly Responder for >=3 weeks during the last 6 weeks of treatment
16. Stool Consistency Weekly Response up to Week 12
17. Weekly number of days with at least 1 stool of consistency 6 or 7 up to Week 12
18. Weekly number of days with at least 1 stool of consistency 6 or 7 during Run-Out Period
19. %Change in weekly number of days with at least 1 stool of consistency 6 or 7 up to Week 12
20. 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
21. Quality of Life at Week 12

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Placebo 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

UZ Leuven

Sponsor organisation

UZ Leuven

Address

Herestraat 49

City

Leuven

Postcode

3000

Country

Belgium

Scientific contact point

Organisation

UZ Leuven

Contact name

Ine De Booser

Public contact point

Organisation

UZ Leuven

Contact name

Ine De Booser

Locations

1 EU/EEA country · 5 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 12 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications