NCT00866788View on ClinicalTrials.gov

A Study of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Antihistamine Treatment (H1)

PHASE2CompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

March 31, 2009

Primary Completion Date

January 31, 2010

Study Completion Date

January 31, 2010

Conditions
Chronic Idiopathic Urticaria
Interventions
DRUG

omalizumab

Administered by subcutaneous injection

DRUG

placebo

Participants received a single subcutaneous placebo injection on Day 0 of the study.

DRUG

H1 antihistamines

Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10 mg QD or Desloratadine 5 mg QD

DRUG

Diphenhydramine

Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

Sponsors

Lead Sponsor

Genentech, Inc.
All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY