Trial Outcomes & Findings for Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema (NCT NCT00375713)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

466 participants

Primary outcome timeframe

Day 7 and 14

Results posted on

2011-08-31

Participant Flow

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.

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).

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	232	234
Overall Study COMPLETED	212	211
Overall Study NOT COMPLETED	20	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Levocetirizine n=168 Participants Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment	Cetirizine n=172 Participants Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment	Total n=340 Participants Total of all reporting groups
Age Continuous	30.17 years STANDARD_DEVIATION 10.09 • n=5 Participants	30.11 years STANDARD_DEVIATION 10.60 • n=7 Participants	30.14 years STANDARD_DEVIATION 10.34 • n=5 Participants
Sex: Female, Male Female	113 Participants n=5 Participants	120 Participants n=7 Participants	233.0 Participants n=5 Participants
Sex: Female, Male Male	55 Participants n=5 Participants	52 Participants n=7 Participants	107.0 Participants n=5 Participants
Region of Enrollment Korea, Republic of	168 participants n=5 Participants	172 participants n=7 Participants	340 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 7 and 14

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Levocetirizine n=168 Participants Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment	Cetirizine n=172 Participants Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). Responder	131 Participants	134 Participants
Responder Status According to Pruritus Severity Score (Response = Mild or None in Pruritus Severity Score). Non-Responder	37 Participants	38 Participants

SECONDARY outcome

Timeframe: Baseline and at endpoint during the 14 day treatment period

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Levocetirizine n=168 Participants Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment	Cetirizine n=172 Participants Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
Change From Baseline in the Mean Pruritus Severity Score at Endpoint During the 14 Day Treatment Period	1.15 Units on a scale Standard Error 0.05	1.21 Units on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: At endpoint during the 14 day treatment period

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Levocetirizine n=168 Participants Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment	Cetirizine n=172 Participants Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
Duration of Pruritus (Stated in Categories) at Endpoint During the 14 Day Treatment Period	2.13 Units on a scale Standard Error 0.05	2.20 Units on a scale Standard Error 0.05

SECONDARY outcome

Timeframe: At endpoint during the 14 day treatment period

Population: All patients in modified ITT except 1 patient in levocetirizine group and 3 patients in cetirizine group who have missing values.

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.

Outcome measures

Outcome measures
Measure	Levocetirizine n=167 Participants Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment	Cetirizine n=169 Participants Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
Global Improvement at Endpoint During the 14 Day Treatment Period Exacerbation	1 Participants	1 Participants
Global Improvement at Endpoint During the 14 Day Treatment Period Marked improvement	47 Participants	52 Participants
Global Improvement at Endpoint During the 14 Day Treatment Period Moderate improvement	62 Participants	54 Participants
Global Improvement at Endpoint During the 14 Day Treatment Period Mild improvement	39 Participants	47 Participants
Global Improvement at Endpoint During the 14 Day Treatment Period No change	18 Participants	15 Participants

Adverse Events

Levocetirizine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Cetirizine

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Levocetirizine n=209 participants at risk Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment	Cetirizine n=214 participants at risk Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia acute	0.48% 1/209 • Number of events 1	0.00% 0/214

Other adverse events

Other adverse events
Measure	Levocetirizine n=209 participants at risk Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment	Cetirizine n=214 participants at risk Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
Respiratory, thoracic and mediastinal disorders Rhinitis	0.00% 0/209	2.3% 5/214 • Number of events 5

Additional Information

UCB Clinical Trial Call Center

UCB Pharma

Phone: + 1 877 822 9493

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER