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Ebastine Versus Mebeverine in IBS Patients

Primary Purpose

IBS - Irritable Bowel Syndrome, IBS

Status
Recruiting
Phase
Phase 3
Locations
Belgium
Study Type
Interventional
Intervention
Ebastine
Duspatalin
Sponsored by
Guy Boeckxstaens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for IBS - Irritable Bowel Syndrome focused on measuring ebastine, duspatalin, IBS, Irritable Bowel Syndrome

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AZ St-MaartenRecruiting
  • UZLeuvenRecruiting
  • AZ St-LucasRecruiting
  • GZARecruiting
  • UZARecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ebastine verum and duspatalin placebo

Duspatalin verum and ebastine placebo

Arm Description

Outcomes

Primary Outcome Measures

Clinical Response to Abdominal Pain Intensity
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.
Clinical Response to Global Relief of Symptoms
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.

Secondary Outcome Measures

Full Information

First Posted
April 4, 2023
Last Updated
May 10, 2023
Sponsor
Guy Boeckxstaens
Collaborators
Fund for Scientific Research, Flanders, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT05815602
Brief Title
Ebastine Versus Mebeverine in IBS Patients
Official Title
Multicenter Randomized Controlled Clinical Trial Comparing Ebastine and Mebeverine as Treatment of Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
October 1, 2026 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Guy Boeckxstaens
Collaborators
Fund for Scientific Research, Flanders, Belgium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Multicenter randomized controlled clinical trial comparing ebastine and mebeverine as treatment of irritable bowel syndrome Trial rationale To perform a randomized superiority trial comparing the clinical efficacy of ebastine and mebeverine 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
IBS - Irritable Bowel Syndrome, IBS
Keywords
ebastine, duspatalin, IBS, Irritable Bowel Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ebastine verum and duspatalin placebo
Arm Type
Experimental
Arm Title
Duspatalin verum and ebastine placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Ebastine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Duspatalin
Intervention Description
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 Outcome Measure Information:
Title
Clinical Response to Abdominal Pain Intensity
Description
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.
Time Frame
12 weeks of study medication administration
Title
Clinical Response to Global Relief of Symptoms
Description
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.
Time Frame
12 weeks of study medication administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Koen Bellens, MSc.
Phone
+3216341943
Ext
41943
Email
koen.bellens@kuleuven.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Boeckxstaens, prof. dr.
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ St-Maarten
City
Mechelen
State/Province
Antwerpen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Inez Mestdagh
Phone
+3215891664
Email
Inez.Mestdagh@Emmaus.be
First Name & Middle Initial & Last Name & Degree
Jurgen Van Dongen
Facility Name
UZLeuven
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koen Bellens, MSc.
Phone
+3216341943
Email
koen.bellens@kuleuven.be
First Name & Middle Initial & Last Name & Degree
Guy Boeckxstaens, prof. dr.
Facility Name
AZ St-Lucas
City
Brugge
State/Province
West-Vlaanderen
ZIP/Postal Code
8310
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Glorieux
Phone
+3250365711
Email
clinical.trials@stlucas.be
First Name & Middle Initial & Last Name & Degree
Joris Arts
Facility Name
GZA
City
Antwerpen
ZIP/Postal Code
2000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sara Nullens
Phone
+3232852000
Email
sara.nullens@gza.be
First Name & Middle Initial & Last Name & Degree
Sara Nullens
Facility Name
UZA
City
Antwerpen
ZIP/Postal Code
2000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eveline Vanhaesebrouck
Phone
+3238214491
Email
Eveline.Vanhaesebrouck@uza.be
First Name & Middle Initial & Last Name & Degree
Heiko De Schepper

12. IPD Sharing Statement

Plan to Share IPD
No

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Ebastine Versus Mebeverine in IBS Patients

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