Status:
COMPLETED
Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
Lead Sponsor:
UCB Pharma
Conditions:
Dermatitis
Eczema
Eligibility:
All Genders
15+ years
Phase:
PHASE3
Brief Summary
Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the 2 weeks treat...
Eligibility Criteria
Inclusion
- Subjects diagnosed as having atopic dermatitis, contact dermatitis, prurigo, pruritus in the dermatitis and eczema
- Subjects who require and agree to the concomitant use of a topical steroid preparation.
- Subjects having a minimum level of pruritus and having used topical hydrocortisone during the run -in period
- Written informed consent signed and dated by subject/legal guardian
- Female subjects with childbearing potential are eligible if they use a medically accepted contraceptive method and have a negative pregnancy test.
Exclusion
- Subjects with a known hypersensitivity to cetirizine or levocetirizine
- Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
- Have used forbidden concomitant medications or having not respected adequate wash-out periods as defined by the protocol
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2006
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT00375713
Start Date
October 1 2005
End Date
May 1 2006
Last Update
August 31 2011
Active Locations (3)
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1
Gyeunggi-do, South Korea
2
Kyeonggi-Do, South Korea
3
Seoul, South Korea