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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

NCT ID: NCT00375713

Last Updated: 2011-08-31

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

466 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2006-05-31

Brief Summary

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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

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Conditions

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Dermatitis Eczema

Keywords

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Dermatitis Eczema Pruritus Xyzal Zyrtec Levocetirizine Cetirizine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Levocetirizine

Levocetirizine + Cetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days

Group Type EXPERIMENTAL

Levocetirizine

Intervention Type DRUG

1 Levocetirizine 5mg tablet per day before bedtime for 14 days

Placebo-Cetirizine

Intervention Type DRUG

1 Placebo-Cetirizine tablet per day before bedtime for 14 days

Standard topical steroid (1% hydrocortisone) ointment

Intervention Type DRUG

1% hydrocortisone ointment, applied 2-3 times a day to all affected areas

Cetirizine

Cetirizine + Levocetirizine-Placebo + Standard Topical Steroid (1% hydrocortisone) Ointment for 14 days

Group Type ACTIVE_COMPARATOR

Cetirizine

Intervention Type DRUG

1 Cetirizine 10mg tablet per day before bedtime for 14 days.

Placebo-Levocetirizine

Intervention Type DRUG

1 Placebo-Levocetirizine tablet per day before bedtime for 14 days

Standard topical steroid (1% hydrocortisone) ointment

Intervention Type DRUG

1% hydrocortisone ointment, applied 2-3 times a day to all affected areas

Interventions

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Levocetirizine

1 Levocetirizine 5mg tablet per day before bedtime for 14 days

Intervention Type DRUG

Cetirizine

1 Cetirizine 10mg tablet per day before bedtime for 14 days.

Intervention Type DRUG

Placebo-Levocetirizine

1 Placebo-Levocetirizine tablet per day before bedtime for 14 days

Intervention Type DRUG

Placebo-Cetirizine

1 Placebo-Cetirizine tablet per day before bedtime for 14 days

Intervention Type DRUG

Standard topical steroid (1% hydrocortisone) ointment

1% hydrocortisone ointment, applied 2-3 times a day to all affected areas

Intervention Type DRUG

Other Intervention Names

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Xyzal® Zyrtec®

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Pharma

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kevin Beh, MD

Role: STUDY_DIRECTOR

UCB Pharma

Locations

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Gyeunggi-do, , South Korea

Site Status

Kyeonggi-Do, , South Korea

Site Status

Seoul, , South Korea

Site Status

Countries

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South Korea

Related Links

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http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

FDA Safety Alerts and Recalls

Other Identifiers

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A00410

Identifier Type: -

Identifier Source: org_study_id