Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00375713
First received: September 12, 2006
Last updated: August 30, 2011
Last verified: December 2009

September 12, 2006
August 30, 2011
October 2005
May 2006   (final data collection date for primary outcome measure)
Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). [ Time Frame: Day 7 and 14 ] [ Designated as safety issue: No ]
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.
To assess the non-inferiority in efficacy and safety of levocetirizine to cetirizine in subjects aged 15 years and above suffering from dermatitis and eczema with pruritus symptoms
Complete list of historical versions of study NCT00375713 on ClinicalTrials.gov Archive Site
  • Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period [ Time Frame: Baseline and at endpoint during the 14 day treatment period ] [ Designated as safety issue: No ]
    The Pruritus Score Scale ranges from 0 to 3 (3 for Severe, 2 for Moderate, 1 for Mild and 0 for None). Endpoint is at visit 4 on day 14 or at an earlier timepoint at study completion.
  • Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period [ Time Frame: At endpoint during the 14 day treatment period ] [ Designated as safety issue: No ]
    Duration of pruritus was categorized as follows: 3 if > 6 hours/24hr, 2 if 1 to 6 hours/24hr, 1 if less than 1 hour/24hr, and 0 if No pruritus. The endpoint is visit 4 on day 14 or at an earlier time point at study completion.
  • Global Improvement at Endpoint During the 14 Day Treatment Period [ Time Frame: At endpoint during the 14 day treatment period ] [ Designated as safety issue: No ]
    Global improvement is measured on an ordered nominal scale ranging from marked improvement to exacerbation (see categories in the table). The endpoint is visit 4 on day 14 or at an earlier time point at study completion.
  • Change in the mean pruritus severity score
  • Change in Duration of pruritus
  • Change in Global Improvement Rate (GIR)
Not Provided
Not Provided
 
Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Dermatitis
  • Eczema
  • Drug: Levocetirizine
    1 Levocetirizine 5mg tablet per day before bedtime for 14 days
    Other Name: Xyzal®
  • Drug: Cetirizine
    1 Cetirizine 10mg tablet per day before bedtime for 14 days.
    Other Name: Zyrtec®
  • Drug: Placebo-Levocetirizine
    1 Placebo-Levocetirizine tablet per day before bedtime for 14 days
  • Drug: Placebo-Cetirizine
    1 Placebo-Cetirizine tablet per day before bedtime for 14 days
  • Drug: Standard topical steroid (1% hydrocortisone) ointment
    1% hydrocortisone ointment, applied 2-3 times a day to all affected areas
  • Experimental: Levocetirizine
    Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
    Interventions:
    • Drug: Levocetirizine
    • Drug: Placebo-Cetirizine
    • Drug: Standard topical steroid (1% hydrocortisone) ointment
  • Active Comparator: Cetirizine
    Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
    Interventions:
    • Drug: Cetirizine
    • Drug: Placebo-Levocetirizine
    • Drug: Standard topical steroid (1% hydrocortisone) ointment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
466
May 2006
May 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Both
15 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00375713
A00410
No
UCB, Inc.
UCB, Inc.
Not Provided
Study Director: Kevin Beh, MD UCB, Inc.
UCB, Inc.
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP