Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial

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

NCT01908465

S55485

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

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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