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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

NCT00375713 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 466

Last updated 2011-08-31

Study results available
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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

Conditions

Interventions

DRUG

Levocetirizine

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

DRUG

Cetirizine

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

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

Sponsors & Collaborators

  • UCB Pharma

    lead INDUSTRY

Principal Investigators

  • Kevin Beh, MD · UCB Pharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2006-05-31
Completion
2006-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00375713 on ClinicalTrials.gov