Irritable Bowel Syndrome (IBS) Treatment With H1-receptor Antagonists

Catholic University (KU) of Leuven

Status and phase: Completed; Phase 4

Conditions: Irritable Bowel Syndrome

Treatments: Drug: ebastine; Drug: placebo capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT01144832

S51638

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).

End points:

End point is the effect of treatment on clinical symptoms and visceral hypersensitivity which will be evaluated with a barostat test.

Enrollment: 55 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Irritable Bowel Syndrome (ROME III criteria)
• age 18-65 years

Exclusion criteria

• medication: antidepressants or H1-receptor antagonists
• pregnancy, breast feeding
• co-morbidity: severe kidney- and/or liver disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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55 participants in 2 patient groups, including a placebo group

placebo capsule

Placebo Comparator group

Treatment:

Drug: placebo capsule

ebastine

Active Comparator group

Treatment:

Drug: ebastine