Trial Outcomes & Findings for Safety Study of Levocetirizine and Fexofenadine (NCT NCT01586091)
NCT ID: NCT01586091
Last Updated: 2019-10-04
Results Overview
We measured drug concentrations and various aspects of skin provocation testing such as itch intensity and wheal size. Measurements made at each time point were as followed: Pruritus was assessed every 30 s for 10 min after SPT using a visual analogue scale (VAS) score with a "0" and "100" at the two ex- tremes of an unmarked 100 mm line with higher values indicating greater puritus. The mean VAS for each 10 min was calculated and used as a primary end Point.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
18 participants
Primary outcome timeframe
up to 10 minutes after skin prick test performed 24 hours after drug administration
Results posted on
2019-10-04
Participant Flow
Participant milestones
| Measure |
Day 1
Intake of Placebo- Fexofenadine 6 mg - Levocetirizin 5 mg
|
Day 2
Intake of Fexofenadine 6 mg - Levocetirizin 5 mg - Placebo
|
Day 3
Intake of Placebo- Levocetirizin 5 mg- Fexofenadine 60
|
|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
Baseline characteristics by cohort
| Measure |
Day 2
n=6 Participants
Intake on 0 hours and 12 hours Intake Levocetirizn
|
Day 3
n=6 Participants
Intake on 0 hours and 12 hours Intake Fexofenadine
|
Day 1
n=6 Participants
Intake on 0 hours and 12 hours Intake Placebo
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=107 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=206 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=7 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
3 Participants
n=107 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
3 Participants
n=206 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
9 Participants
n=7 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=107 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=206 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=7 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=107 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=206 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=7 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
|
Race (NIH/OMB)
White
|
3 Participants
n=99 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
3 Participants
n=107 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
3 Participants
n=206 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
9 Participants
n=7 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=107 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=206 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=7 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=107 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=206 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
0 Participants
n=7 Participants • A total of 9 Patients (includes Asian and Caucasian) per Arm/Group were analysed.
|
|
Region of Enrollment
Germany
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: up to 10 minutes after skin prick test performed 24 hours after drug administrationPopulation: Please see Outcome Measure Description. Itch was measured using a 10 point VAS.
We measured drug concentrations and various aspects of skin provocation testing such as itch intensity and wheal size. Measurements made at each time point were as followed: Pruritus was assessed every 30 s for 10 min after SPT using a visual analogue scale (VAS) score with a "0" and "100" at the two ex- tremes of an unmarked 100 mm line with higher values indicating greater puritus. The mean VAS for each 10 min was calculated and used as a primary end Point.
Outcome measures
| Measure |
Levocetirizin
n=18 Participants
5 mg once daily
|
Fexofenadine
n=18 Participants
60 mg twice daily
|
Placebo
n=18 Participants
Placebo as comparison to Levocetirizin
|
|---|---|---|---|
|
Pruritus as Assessed by the VAS Score
|
11.5 mm
Standard Error 16.4
|
25.4 mm
Standard Error 35.3
|
46.0 mm
Standard Error 44.6
|
PRIMARY outcome
Timeframe: 24 hours per treatmentPopulation: Please see Outcome measure description. Flair Diameter was measured in mm.
Flaire diameter was measured with a transparent ruler as the mean of the largest diameter and the diameter at right angles to this.
Outcome measures
| Measure |
Levocetirizin
n=18 Participants
5 mg once daily
|
Fexofenadine
n=18 Participants
60 mg twice daily
|
Placebo
n=18 Participants
Placebo as comparison to Levocetirizin
|
|---|---|---|---|
|
Flaire Diameter (mm)
|
69.4 mm
Standard Error 24.8
|
20.4 mm
Standard Error 10.0
|
39.9 mm
Standard Error 13.6
|
PRIMARY outcome
Timeframe: 24 hours per treatmentPopulation: Please see Outcome Measure Description. Wheal volume was measured in cm3. The units of measure are provided in the report of the this study protocol.
Wheal volume was measured by a non-contact three dimensional measurement system (PRIMOS contact, GFM Messtechnik GmbH, Teltow, Germany).
Outcome measures
| Measure |
Levocetirizin
n=18 Participants
5 mg once daily
|
Fexofenadine
n=18 Participants
60 mg twice daily
|
Placebo
n=18 Participants
Placebo as comparison to Levocetirizin
|
|---|---|---|---|
|
Wheal Volume (cm3)
|
174.6 cm3
Standard Error 50.9
|
35.2 cm3
Standard Error 13.5
|
106.3 cm3
Standard Error 39.5
|
Adverse Events
Levocetirizine
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Fexofenadine
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Levocetirizine
n=18 participants at risk
5 mg once daily
|
Fexofenadine
n=18 participants at risk
60 mg twice daily, oral
|
Placebo
n=18 participants at risk
Placebo against Levocetirzine
|
|---|---|---|---|
|
Gastrointestinal disorders
fatigue
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
0.00%
0/18 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
0.00%
0/18 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
|
Skin and subcutaneous tissue disorders
pain at the puncture site of the intravenous catheter
|
0.00%
0/18 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory tract infection
|
11.1%
2/18 • Number of events 2 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
0.00%
0/18 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
|
Infections and infestations
bacterial inflammation of the finger
|
0.00%
0/18 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
0.00%
0/18 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
|
Social circumstances
pain in the knee joint
|
0.00%
0/18 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
0.00%
0/18 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
5.6%
1/18 • Number of events 1 • Adverse Events were collected on the following time points: 0 (baseline), 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours
|
Additional Information
Professor Marcus Maurer
University of Charité Berlin; Dpt. of Dermatology and Allergy
Phone: +49 30 450 518 043
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place