Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal� (Levocetirizine) vs Zyrtec� (Cetirizine) in Subjects With Dermatitis and Eczema
Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dermatitis; Eczema
Intervention: Levocetirizine (Drug); Cetirizine (Drug); Placebo-Levocetirizine (Drug); Placebo-Cetirizine (Drug); Standard topical steroid (1% hydrocortisone) ointment (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: UCB Pharma Official(s) and/or principal investigator(s): Kevin Beh, MD, Study Director, Affiliation: UCB Pharma
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
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).
Secondary outcome: Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment PeriodDuration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period Global Improvement at Endpoint During the 14 Day Treatment Period
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Gyeunggi-do, Korea, Republic of
Kyeonggi-Do, Korea, Republic of
Seoul, Korea, Republic of
Additional Information
FDA Safety Alerts and Recalls Product Information
Starting date: October 2005
Last updated: August 30, 2011
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