| September 12, 2006 |
| September 11, 2009 |
| 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 ] |
| 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 ]
- 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 ]
- 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 ]
|
- Change in the mean pruritus severity score
- Change in Duration of pruritus
- Change in Global Improvement Rate (GIR)
|
| |
| 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 |
| |
| Phase III |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
|
|
- Drug: Levocetirizine
- Drug: Cetirizine
- Drug: Placebo-Levocetirizine
- Drug: Placebo-Cetirizine
- Drug: Standard topical steroid (1% hydrocortisone) ointment
|
- Experimental: Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
- Active Comparator: Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days
|
| |
| |
| 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 |
| Study Director, UCB |
| A00410 |
| UCB, Inc. |
|
| Study Director: |
Kevin Beh, MD |
UCB, Inc. |
|
|
| UCB, Inc. |
| September 2009 |
