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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:


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