Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma
ClinicalTrials.gov Identifier:
NCT00375713
First received: September 12, 2006
Last updated: August 30, 2011
Last verified: December 2009
Results First Received: July 8, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Dermatitis
Eczema
Interventions: Drug: Levocetirizine
Drug: Cetirizine
Drug: Placebo-Levocetirizine
Drug: Placebo-Cetirizine
Drug: Standard topical steroid (1% hydrocortisone) ointment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
506 patients were screened and 466 randomized. Due to a packaging error 99 patients were excluded from the efficacy analysis according to the advice of the Korean FDA. The Reported Adverse Events section refers to the Safety Population (N= 423) defined as all patients treated with at least one safety evaluation without entry criteria violation.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participant workflow refers to all randomized subjects whereas in Baseline Characteristics numbers and statistics for the modified Intent To Treat (m-ITT) population are presented (see definition of m-ITT population in the Outcome Measure section).

Reporting Groups
  Description
Levocetirizine Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
Cetirizine Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment

Participant Flow:   Overall Study
    Levocetirizine     Cetirizine  
STARTED     232 [1]   234 [2]
COMPLETED     212 [3]   211 [4]
NOT COMPLETED     20     23  
[1] Randomized population (N=232).
[2] Randomized population (N=234).
[3] 20 Patients were not treated or discontinued after randomization in Levocetirizine group.
[4] 23 Patients were not treated or discontinued after randomization in Cetirizine group.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Levocetirizine Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
Cetirizine Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
Total Total of all reporting groups

Baseline Measures
    Levocetirizine     Cetirizine     Total  
Number of Participants  
[units: participants]
  168     172     340  
Age  
[units: years]
Mean ± Standard Deviation
  30.17  ± 10.09     30.11  ± 10.60     30.14  ± 10.34  
Gender  
[units: participants]
     
Female     113     120     233  
Male     55     52     107  
Region of Enrollment  
[units: participants]
     
Korea, Republic of     168     172     340  



  Outcome Measures
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1.  Primary:   Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).   [ Time Frame: Day 7 and 14 ]

2.  Secondary:   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 ]

3.  Secondary:   Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period   [ Time Frame: At endpoint during the 14 day treatment period ]

4.  Secondary:   Global Improvement at Endpoint During the 14 Day Treatment Period   [ Time Frame: At endpoint during the 14 day treatment period ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
phone: + 1 877 822 9493


No publications provided


Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00375713     History of Changes
Other Study ID Numbers: A00410
Study First Received: September 12, 2006
Results First Received: July 8, 2009
Last Updated: August 30, 2011
Health Authority: Korea: Food and Drug Administration