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
  Purpose

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


Condition Intervention Phase
Dermatitis
Eczema
Drug: Levocetirizine
Drug: Cetirizine
Drug: Placebo-Levocetirizine
Drug: Placebo-Cetirizine
Drug: Standard topical steroid (1% hydrocortisone) ointment
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB, Inc.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 466
Study Start Date: October 2005
Study Completion Date: May 2006
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levocetirizine
Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
Drug: Levocetirizine
1 Levocetirizine 5mg tablet per day before bedtime for 14 days
Other Name: Xyzal®
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
Active Comparator: Cetirizine
Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
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: Standard topical steroid (1% hydrocortisone) ointment
1% hydrocortisone ointment, applied 2-3 times a day to all affected areas

  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00375713

Locations
Korea, Republic of
Gyeunggi-do, Korea, Republic of
Kyeonggi-Do, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
UCB, Inc.
Investigators
Study Director: Kevin Beh, MD UCB, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: UCB, Inc.
ClinicalTrials.gov Identifier: NCT00375713     History of Changes
Other Study ID Numbers: A00410
Study First Received: September 12, 2006
Results First Received: July 8, 2009
Last Updated: August 30, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by UCB, Inc.:
Dermatitis
Eczema
Pruritus
Xyzal
Zyrtec
Levocetirizine
Cetirizine

Additional relevant MeSH terms:
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Eczematous
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Cetirizine
Levocetirizine
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Dermatologic Agents
Anti-Allergic Agents
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014