Who is sponsoring NCT00375713?

NCT00375713 is sponsored by UCB Pharma.

What condition does NCT00375713 study?

NCT00375713 studies Dermatitis, Eczema.

What drugs are being tested in NCT00375713?

Interventions: Levocetirizine, Cetirizine, Placebo-Levocetirizine, Placebo-Cetirizine, Standard topical steroid (1% hydrocortisone) ointment.

What is the status of NCT00375713?

NCT00375713 is currently COMPLETED.

Last reviewed 2011-08-30 · How we verify

A Multi-centre, Double-blind, Double-dummy, Randomized, Active-controlled Phase III Study to Evaluate the Efficacy and Safety of Xyzal® 5mg od vs Zyrtec® 10mg od in Subjects Aged 15 Years and Above With Dermatitis and Eczema

NCT00375713 Phase 3 COMPLETED Results posted

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 treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms

Details

Lead sponsor	UCB Pharma
Phase	Phase 3
Status	COMPLETED
Enrolment	466
Start date	2005-10
Completion	2006-05

Conditions

Dermatitis
Eczema

Interventions

Levocetirizine
Cetirizine
Placebo-Levocetirizine
Placebo-Cetirizine
Standard topical steroid (1% hydrocortisone) ointment

Primary outcomes

Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). — Day 7 and 14
A participant is a responder if the pruritus severity score is assessed as mild or none, otherwise it is a non-responder. The responder status is defined at day 14, except if the investigator assessed the subject as a responder at day 7. The Pruritus Score is in general defined as: 3 for Severe, 2 for Moderate, 1 for Mild and 0 for None.

Countries

South Korea