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Trial record 1 of 1 for:    NCT00525382
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Study to Compare the Efficacy and Safety Between Levocetirizine and Loratadine for Chronic Idiopathic Urticaria

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ClinicalTrials.gov Identifier: NCT00525382
Recruitment Status : Completed
First Posted : September 5, 2007
Last Update Posted : December 12, 2013
Information provided by:
UCB Pharma

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

Condition or disease Intervention/treatment Phase
Urticaria Drug: levocetirizine dihydrochloride Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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)
Study Start Date : August 2003
Actual Primary Completion Date : March 2004
Actual Study Completion Date : March 2004

Primary Outcome Measures :
  1. pruritus severity, assessed by the investigator over 2 weeks of treatment [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00525382

Sponsors and Collaborators
UCB Pharma
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Study Director: UCB Clinical Trial Call Center UCB Pharma
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ClinicalTrials.gov Identifier: NCT00525382    
Other Study ID Numbers: A00334
First Posted: September 5, 2007    Key Record Dates
Last Update Posted: December 12, 2013
Last Verified: September 2009
Keywords provided by UCB Pharma:
Levocetirizine dihydrochloride
Xyzal tablets
Additional relevant MeSH terms:
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Chronic Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs