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Trial Outcomes & Findings for Is Levocetirizine Less Sedating Than Cetirizine? (NCT NCT00826943)

NCT ID: NCT00826943

Last Updated: 2014-02-20

Results Overview

Epworth Sleepiness Scale ratings (0 to 24); higher scores = increased sedation. This was measured over the 36 days of the study (at the end of each washout period and each intervention period); measured on days 5, 12, 17, 24, 29, and 36. This was mean data for all interventions.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

36 days of the study

Results posted on

2014-02-20

Participant Flow

Participant milestones

Participant milestones
Measure
C Then P Then L
cetirizine 10 mg daily x 7 days then placebo daily x 7 days then levocetirizine 5 mg daily x 7 days (wash out periods before and after each)
L Then P Then C
Levocetirizine 5 mg daily x 7 days then placebo daily x 7 days then cetiriznie 10 mg daily x 7 days (wash out periods before and after each)
P Then L Then C
placebo daily x 7 days then levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days (wash out periods before and after each)
P Then C Then L
placebo daily x 7 days then cetirizine 10 mg daily x 7 days then levocetirizine daily x 7 days (wash out periods before and after each)
C Then L Then P
cetirizine 10 mg daily x 7 days then levocetirizine 5 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
L Then C Then P
Levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
Overall Study
STARTED
2
6
4
5
7
6
Overall Study
COMPLETED
2
6
4
5
6
6
Overall Study
NOT COMPLETED
0
0
0
0
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
C Then P Then L
cetirizine 10 mg daily x 7 days then placebo daily x 7 days then levocetirizine 5 mg daily x 7 days (wash out periods before and after each)
L Then P Then C
Levocetirizine 5 mg daily x 7 days then placebo daily x 7 days then cetiriznie 10 mg daily x 7 days (wash out periods before and after each)
P Then L Then C
placebo daily x 7 days then levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days (wash out periods before and after each)
P Then C Then L
placebo daily x 7 days then cetirizine 10 mg daily x 7 days then levocetirizine daily x 7 days (wash out periods before and after each)
C Then L Then P
cetirizine 10 mg daily x 7 days then levocetirizine 5 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
L Then C Then P
Levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
Overall Study
Withdrawal by Subject
0
0
0
0
1
0

Baseline Characteristics

Is Levocetirizine Less Sedating Than Cetirizine?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
All Study Participants
n=29 Participants
Cross Over (all participants received all interventions)
Age, Categorical
<=18 years
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
28 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
Age, Continuous
37.5 years
STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male
Female
24 Participants
n=5 Participants
Sex: Female, Male
Male
5 Participants
n=5 Participants
Region of Enrollment
United States
29 participants
n=5 Participants

PRIMARY outcome

Timeframe: 36 days of the study

Population: per protocol

Epworth Sleepiness Scale ratings (0 to 24); higher scores = increased sedation. This was measured over the 36 days of the study (at the end of each washout period and each intervention period); measured on days 5, 12, 17, 24, 29, and 36. This was mean data for all interventions.

Outcome measures

Outcome measures
Measure
Placebo
n=29 Participants
Cross Over (all participants received all interventions)
Levocetirizine
n=29 Participants
cross over (all participants received all interventions)
Cetirizine
n=29 Participants
cross over = all participants received all interventions
Modified Epworth Sleepiness Scale
6.14 units on a scale
Standard Deviation 4.58
6.69 units on a scale
Standard Deviation 4.05
7.48 units on a scale
Standard Deviation 5.31

PRIMARY outcome

Timeframe: duration of study (36 days)

Population: per protocol

Likert score range 1 to 9 (no sedation to extreme sedation). Highers scores indicate increased sedation. This was measured on days days 5, 12, 17, 24, 29, and 36 of the study. This was mean data for all interventions.

Outcome measures

Outcome measures
Measure
Placebo
n=29 Participants
Cross Over (all participants received all interventions)
Levocetirizine
n=29 Participants
cross over (all participants received all interventions)
Cetirizine
n=29 Participants
cross over = all participants received all interventions
Likert Score Rating Global Sedation
2.80 Likert score
Standard Deviation 1.67
3.07 Likert score
Standard Deviation 1.92
3.54 Likert score
Standard Deviation 2.17

SECONDARY outcome

Timeframe: same as primary outcome measure (obtain on days 5, 12, 17, 24, 29, and 36)

Total Four Symptom Scores (TFSS) ranging 0 to 12. Increased scores indicate increased symptoms. This was measured on days 5, 12, 17, 24, 29, and 36 of the study. The mean TFSS for patients receiving placebo, cetirizine, and levocetirizine was then calculated. This was mean data for all interventions.

Outcome measures

Outcome measures
Measure
Placebo
n=29 Participants
Cross Over (all participants received all interventions)
Levocetirizine
n=29 Participants
cross over (all participants received all interventions)
Cetirizine
n=29 Participants
cross over = all participants received all interventions
Total Four Symptom Scores (Allergy Symptoms)
4.41 TFSS scores
Standard Deviation 3.76
3.14 TFSS scores
Standard Deviation 2.67
2.67 TFSS scores
Standard Deviation 2.44

Adverse Events

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Levocetirizine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Cetirizine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Douglas Tzanetos

Vanderbilt University

Phone: 615-942-7971

Results disclosure agreements

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