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

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00525382
First received: September 4, 2007
Last updated: September 9, 2009
Last verified: September 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Urticaria
 Drug: levocetirizine dihydrochloride
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
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
U.S. FDA Resources

Further study details as provided by UCB, Inc.:

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, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00525382     History of Changes
Other Study ID Numbers: A00334
Study First Received: September 4, 2007
Last Updated: September 9, 2009
Health Authority: China: Department of Health, Pharmaceuticals registration and Import/Export control section

Keywords provided by UCB, Inc.:
Levocetirizine dihydrochloride
Xyzal tablets

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Loratadine
Cetirizine
Levocetirizine
Antipruritics
Dermatologic Agents
 Therapeutic Uses
Pharmacologic Actions
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013