Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria

This study has been completed.

First Received: September 4, 2007 Last Updated: March 6, 2008 History of Changes

Sponsored by:	UCB
Information provided by:	UCB
ClinicalTrials.gov Identifier:	NCT00525382

Purpose

Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria.

Condition	Intervention	Phase
Urticaria	Drug: levocetirizine dihydrochloride	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment
Official Title:	A Study Evaluating the Efficacy and Safety of 5 mg Levocetirizine Oral Tablets, Once Daily Versus 10 mg Loratadine Oral Tablets, Once Daily for the Treatment of Chronic Idiopathic Urticaria (CIU)

Resource links provided by NLM:

MedlinePlus related topics: Hives

Drug Information available for: Loratadine Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by UCB:

Primary Outcome Measures:

pruritus severity, assessed by the investigator over 2 weeks of treatment [ Time Frame: 2 weeks ]

Secondary Outcome Measures:

Symptom score reducing index; subject severity score at 1 and 2 weeks; investigator global evaluation after 2 weeks of treatment; safety [ Time Frame: 2 weeks ]

Enrollment:	134
Study Start Date:	August 2003
Study Completion Date:	March 2004
Primary Completion Date:	March 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female, 18 to 60 years old (inclusive
having chronic idiopathic urticaria
at least 6-weeks history of CIU, had at least 3 days of wheals presence/week
moderate to severe CIU defined as pruritus score ≥ 2, number of wheals ≥ 2, and total symptoms CIU score ≥ 2 at randomization

Exclusion Criteria:

Asthma requiring daily drug therapy other than ß2 inhaled agonists taken prn
atopic dermatitis or urticaria requiring an antihistamine treatment or the administration of oral or dermal topical corticosteroids
urticaria caused by physical factors or other known factors
cholinergic urticaria
had urticaria due to other systemic disorders
were on antihistamine drug currently

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00525382

Sponsors and Collaborators

UCB

Investigators

Study Director:

Isabelle Campine

UCB

More Information

No publications provided

Study ID Numbers:	A00334
Study First Received:	September 4, 2007
Last Updated:	March 6, 2008
ClinicalTrials.gov Identifier:	NCT00525382 History of Changes
Health Authority:	China: Department of Health, Pharmaceuticals registration and Import/Export control section

Keywords provided by UCB:

Levocetirizine dihydrochloride
Xyzal tablets

Study placed in the following topic categories:

Neurotransmitter Agents
Skin Diseases
Urticaria
Anti-Allergic Agents
Cetirizine
Histamine
Hypersensitivity

Loratadine
Histamine Antagonists
Levocetirizine
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine phosphate

Additional relevant MeSH terms:

Skin Diseases, Vascular
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Skin Diseases
Immune System Diseases
Physiological Effects of Drugs
Histamine Agents
Urticaria
Anti-Allergic Agents

Cetirizine
Pharmacologic Actions
Hypersensitivity
Histamine Antagonists
Levocetirizine
Therapeutic Uses
Hypersensitivity, Immediate
Histamine H1 Antagonists
Histamine H1 Antagonists, Non-Sedating

ClinicalTrials.gov processed this record on July 02, 2009