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Trial record 1 of 1 for:    NCT00375713
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Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00375713
Recruitment Status : Completed
First Posted : September 13, 2006
Results First Posted : October 14, 2009
Last Update Posted : August 31, 2011
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Tracking Information
First Submitted Date  ICMJE September 12, 2006
First Posted Date  ICMJE September 13, 2006
Results First Submitted Date  ICMJE July 8, 2009
Results First Posted Date  ICMJE October 14, 2009
Last Update Posted Date August 31, 2011
Study Start Date  ICMJE October 2005
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2006)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2009)
  • 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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2006)
  • Change in the mean pruritus severity score
  • Change in Duration of pruritus
  • Change in Global Improvement Rate (GIR)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
Official Title  ICMJE 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
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 treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from dermatitis and eczema with pruritus symptoms
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dermatitis
  • Eczema
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 13, 2009)
466
Original Enrollment  ICMJE
 (submitted: September 12, 2006)
390
Actual Study Completion Date  ICMJE May 2006
Actual Primary Completion Date May 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00375713
Other Study ID Numbers  ICMJE A00410
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party UCB Pharma
Study Sponsor  ICMJE UCB Pharma
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Kevin Beh, MD UCB Pharma
PRS Account UCB Pharma
Verification Date December 2009

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