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Trial record 1 of 1 for:    NCT00375713
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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

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ClinicalTrials.gov Identifier: NCT00375713
Recruitment Status : Completed
First Posted : September 13, 2006
Results First Posted : October 14, 2009
Last Update Posted : August 31, 2011
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, 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
Enrollment 466
Recruitment Details 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 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).
Arm/Group Title Levocetirizine Cetirizine
Hide Arm/Group Description Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
Period Title: Overall Study
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.
Arm/Group Title Levocetirizine Cetirizine Total
Hide Arm/Group Description Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment Total of all reporting groups
Overall Number of Baseline Participants 168 172 340
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 168 participants 172 participants 340 participants
30.17  (10.09) 30.11  (10.60) 30.14  (10.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 168 participants 172 participants 340 participants
Female
113
  67.3%
120
  69.8%
233.0
Male
55
  32.7%
52
  30.2%
107.0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic of Number Analyzed 168 participants 172 participants 340 participants
168 172 340
1.Primary Outcome
Title Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score).
Hide Description A participant is a responder if the pruritus severity score is assessed as mild or none, otherwise it is a non-responder. The responder status is defined at day 14, except if the investigator assessed the subject as a responder at day 7. The Pruritus Score is in general defined as: 3 for Severe, 2 for Moderate, 1 for Mild and 0 for None.
Time Frame Day 7 and 14
Hide Outcome Measure Data
Hide Analysis Population Description
The modified ITT population is defined as all randomized patients who received the study drug, except the patients who did not meet the entry criteria, took prohibited medication during the study period, did not have any available data for efficacy evaluation and who were enrolled with packing errors.
Arm/Group Title Levocetirizine Cetirizine
Hide Arm/Group Description:
Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
Overall Number of Participants Analyzed 168 172
Measure Type: Number
Unit of Measure: Participants
Responder 131 134
Non-Responder 37 38
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levocetirizine, Cetirizine
Comments The lower bound of the 95% two sided confidence interval for the difference (Levocetirizine - Cetirizine) in percentage of responders is compared to the pre-set threshold for non inferiority (-10% which is equal to -0.1 for the proportion of responders). Standard method for estimation of the difference in proportions incl. confidence interval using normal approximation is used.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The pre-set threshold for non inferiority is -10%.
Method of Estimation Estimation Parameter Difference in proportion of responders
Estimated Value 0.00069213
Confidence Interval 95%
-0.0875 to 0.0888
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period
Hide Description The Pruritus Score Scale ranges from 0 to 3 (3 for Severe, 2 for Moderate, 1 for Mild and 0 for None). Endpoint is at visit 4 on day 14 or at an earlier timepoint at study completion.
Time Frame Baseline and at endpoint during the 14 day treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in modified Intent-to-treat population. Last Observation Carried Forward principle was applied to the missing data of the pruritus severity score on the previous day of the randomization.
Arm/Group Title Levocetirizine Cetirizine
Hide Arm/Group Description:
Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
Overall Number of Participants Analyzed 168 172
Mean (Standard Error)
Unit of Measure: Units on a scale
1.15  (0.05) 1.21  (0.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levocetirizine, Cetirizine
Comments The mean daily pruritus score at Day 14 visit or at study completion was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4369
Comments [Not Specified]
Method ANCOVA
Comments Pruritus score is adjusted on pruritus Baseline score.
3.Secondary Outcome
Title Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period
Hide Description Duration of pruritus was categorized as follows: 3 if > 6 hours/24hr, 2 if 1 to 6 hours/24hr, 1 if less than 1 hour/24hr, and 0 if No pruritus. The endpoint is visit 4 on day 14 or at an earlier time point at study completion.
Time Frame At endpoint during the 14 day treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in modified Intent-to-treat population. Last Observation Carried Forward principle was applied to the missing data of the pruritus severity score on the previous day of the randomization.
Arm/Group Title Levocetirizine Cetirizine
Hide Arm/Group Description:
Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
Overall Number of Participants Analyzed 168 172
Mean (Standard Error)
Unit of Measure: Units on a scale
2.13  (0.05) 2.20  (0.05)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levocetirizine, Cetirizine
Comments The categorized duration of Pruritus at endpoint during the 14 day treatment period was analyzed using an analysis of covariance (ANCOVA) model, including pruritus severity score of the day before the randomization as a covariate and treatment group as a factor.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3549
Comments [Not Specified]
Method ANCOVA
Comments pruritus severity score at baseline has been used as a covariate.
4.Secondary Outcome
Title Global Improvement at Endpoint During the 14 Day Treatment Period
Hide Description Global improvement is measured on an ordered nominal scale ranging from marked improvement to exacerbation (see categories in the table). The endpoint is visit 4 on day 14 or at an earlier time point at study completion.
Time Frame At endpoint during the 14 day treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
All patients in modified ITT except 1 patient in levocetirizine group and 3 patients in cetirizine group who have missing values.
Arm/Group Title Levocetirizine Cetirizine
Hide Arm/Group Description:
Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
Overall Number of Participants Analyzed 167 169
Measure Type: Number
Unit of Measure: Participants
Marked improvement 47 52
Moderate improvement 62 54
Mild improvement 39 47
No change 18 15
Exacerbation 1 1
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Levocetirizine, Cetirizine
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7518
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments stratified on the prurity severity score at the previous day of randomization.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Levocetirizine Cetirizine
Hide Arm/Group Description Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
All-Cause Mortality
Levocetirizine Cetirizine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Levocetirizine Cetirizine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/209 (0.48%)      0/214 (0.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Leukemia acute * 1  1/209 (0.48%)  1 0/214 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, WHOART
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Levocetirizine Cetirizine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/209 (0.00%)      5/214 (2.34%)    
Respiratory, thoracic and mediastinal disorders     
Rhinitis * 1  0/209 (0.00%)  0 5/214 (2.34%)  5
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, WHOART
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.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: UCB Clinical Trial Call Center
Organization: UCB Pharma
Phone: + 1 877 822 9493
Layout table for additonal information
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00375713    
Other Study ID Numbers: A00410
First Submitted: September 12, 2006
First Posted: September 13, 2006
Results First Submitted: July 8, 2009
Results First Posted: October 14, 2009
Last Update Posted: August 31, 2011