DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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 Period

Duration 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017