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Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial

C

Catholic University (KU) of Leuven

Status and phase

Completed
Phase 4

Conditions

Irritable Bowel Syndrome (IBS)

Treatments

Drug: Ebastine
Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

Purpose:

To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine.

Design:

Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).

Enrollment

200 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Irritable Bowel Syndrome (IBS) (ROME III criteria): subtype with diarrhea or mixed form
  • age 18-65 years

Exclusion criteria

  • IBS subtype with constipation
  • medication: antidepressants or H1-receptor antagonists
  • pregnancy, breast feeding
  • co-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

200 participants in 2 patient groups, including a placebo group

Ebastine
Active Comparator group
Description:
Ebastine
Treatment:
Drug: Ebastine
placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Drug: Placebo

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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