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 Pharma
ClinicalTrials.gov Identifier:
NCT00525382
First received: September 4, 2007
Last updated: December 11, 2013
Last verified: September 2009
  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:


Further study details as provided by UCB Pharma:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00525382     History of Changes
Other Study ID Numbers: A00334
Study First Received: September 4, 2007
Last Updated: December 11, 2013
Health Authority: China: Department of Health, Pharmaceuticals registration and Import/Export control section

Keywords provided by UCB Pharma:
Levocetirizine dihydrochloride
Xyzal tablets

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

ClinicalTrials.gov processed this record on October 22, 2014