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Status:

UNKNOWN

The Efficacy and Safety of Desloratadine With Levocetirizine in Treatment of Chronic Idiopathic Urticaria

Lead Sponsor:

Lotus Pharmaceutical

Conditions:

Chronic Idiopathic Urticaria

Urticaria

Eligibility:

All Genders

12+ years

Phase:

PHASE4

Brief Summary

Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks. Trial design: Randomized, Double-Blin...

Detailed Description

Objective: To compare the efficacy of desloratadine 5mg (Denosin®) and levocetirizine 5mg (Xyzal®) once daily in the treatment of patients with CIU over 6 weeks. Trial design: Randomized, Double-Blin...

Eligibility Criteria

Inclusion

  • The subject or deputy has read or been informed and signed the Informed Consent Agreement and the subject will be willing and able to participate in the study.
  • The subject ≥ 12 years old.
  • The subject with documented signs and symptoms of CIU for 6 weeks or more.
  • The subject has to have a CIU flare for 3 weeks or more before screening, with urticarial lesions visible 3 days or more per week.
  • The overall severities of CIU have to be at least mild to moderate at screening and baseline, subjects have to have at least mild to moderate pruritus, hives have to be apparent at screening, and subjects have intention to treatment.

Exclusion

  • The subject has received any histamine, corticosteroids, ketotifene, systemic antibiotics, nedocromil, sodium cromoglycate or thyroxin drug within 7 days preceding randomization.
  • The subject has received any other investigational drug within one month preceding randomization.
  • The subject has previous non-response to antihistamines.
  • The subject has previous allergy or allergies of desloratadine or levocetirizine.
  • The subject need for long-term corticosteroids treatment (including inhaled, oral and topical dosage).
  • The subject has autoimmune diseases.
  • The subject's urticaria is physical urticaria, cholinergic urticaria or angioedema.
  • The subject is in the situation of pregnancy or breastfeeding.
  • The subject has liver dysfunction (AST ≧ 3 times normal range; ALT ≧ 3 times normal range ) or renal dysfunction (Creatinine ≧ 3.0mg/dl ).
  • The subject is unable to keep an accurate diary of disease symptoms.
  • The subject has significant concomitant illness, which, in the opinion of the investigator, will interfere with the evaluation of the study medications.

Key Trial Info

Start Date :

January 1 2006

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT00346606

Start Date

January 1 2006

Last Update

June 30 2006

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Department of Dermatology National Taiwan University Hospital

Taipei, Taiwan