CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 466 enrolled
Drug / intervention
Levocetirizine +4 moredrug
Likely dose
Levocetirizine 5mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00375713
NCT00375713Phase 3Completed
CompareCT.gov

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

UCB Pharma·interventional·Posted Sep 13, 2006·Updated Aug 31, 2011

In Brief

A Phase 3 clinical trial evaluating Levocetirizine, Cetirizine, and 3 other interventions for Dermatitis and Eczema. Completed, enrolled 466 participants across 3 sites.

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDermatitis, Eczema
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 13, 2006
Enrollment StartOct 1, 2005
Primary CompletionMay 1, 2006
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 19.8 years ago

Interventions

Levocetirizinedrug

1 Levocetirizine 5mg tablet per day before bedtime for 14 days

Cetirizinedrug

1 Cetirizine 10mg tablet per day before bedtime for 14 days.

Placebo-Levocetirizinedrug

1 Placebo-Levocetirizine tablet per day before bedtime for 14 days

Placebo-Cetirizinedrug

1 Placebo-Cetirizine tablet per day before bedtime for 14 days

Standard topical steroid (1% hydrocortisone) ointmentdrug

1% hydrocortisone ointment, applied 2-3 times a day to all affected areas