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Trial record 46 of 66 for:    Levocetirizine

A Study to Compare the Efficacy of Levocetirizine to Placebo in Reducing Symptoms of Seasonal Allergic Rhinitis (SAR) in Sensitive Subjects Exposed to Ragweed Pollen

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ClinicalTrials.gov Identifier: NCT00291642
Recruitment Status : Completed
First Posted : February 14, 2006
Results First Posted : July 20, 2018
Last Update Posted : September 11, 2018
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 Rhinitis
Allergic
Seasonal
Interventions Drug: Placebo drops
Drug: Placebo tablets matching to levocetirizine
Drug: Placebo tablets matching to cetirizine
Drug: Levocetirizine drops
Drug: Levocetirizine tablets
Drug: Cetirizine drops
Drug: Cetirizine tablets
Enrollment 551

Recruitment Details Participant Flow refers to the Randomized Set.
Pre-assignment Details  
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Hide Arm/Group Description A single dose of placebo was administered orally on Day 1. A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Period Title: Overall Study
Started 78 116 119 119 119
Completed 76 116 117 119 118
Not Completed 2 0 2 0 1
Reason Not Completed
Adverse Event             1             0             1             0             1
Patient missed visit             0             0             1             0             0
Intake of prohibited medication             1             0             0             0             0
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg Total Title
Hide Arm/Group Description A single dose of placebo was administered orally on Day 1. A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1. [Not Specified]
Overall Number of Baseline Participants 78 116 119 119 119 551
Hide Baseline Analysis Population Description
Baseline Characteristics refer to the Intention-to-Treat (ITT) Set.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 116 participants 119 participants 119 participants 119 participants 551 participants
<=18 years
1
   1.3%
2
   1.7%
2
   1.7%
6
   5.0%
4
   3.4%
15
   2.7%
Between 18 and 65 years
76
  97.4%
113
  97.4%
114
  95.8%
113
  95.0%
114
  95.8%
530
  96.2%
>=65 years
1
   1.3%
1
   0.9%
3
   2.5%
0
   0.0%
1
   0.8%
6
   1.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 116 participants 119 participants 119 participants 119 participants 551 participants
33.71  (12.46) 33.45  (11.28) 34.36  (12.84) 32.91  (11.30) 34.33  (11.65) 33.76  (11.86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 116 participants 119 participants 119 participants 119 participants 551 participants
Female
42
  53.8%
65
  56.0%
68
  57.1%
65
  54.6%
72
  60.5%
312
  56.6%
Male
36
  46.2%
51
  44.0%
51
  42.9%
54
  45.4%
47
  39.5%
239
  43.4%
1.Primary Outcome
Title Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I
Hide Description

Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:

Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.

Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Time Frame Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid MSC scores in Period I were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Hide Arm/Group Description:
A single dose of placebo was administered orally on Day 1.
A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Overall Number of Participants Analyzed 78 116 119 119 119
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.80  (0.495) -7.15  (0.406) -7.05  (0.401) -7.93  (0.401) -7.54  (0.401)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (PBO), Levocetirizine (LCTZ) 2.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.35
Confidence Interval (2-Sided) 95%
-4.61 to -2.09
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.640
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (PBO), Levocetirizine (LCTZ) 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.25
Confidence Interval (2-Sided) 95%
-4.50 to -2.00
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.637
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (PBO), Cetirizine (CTZ) 5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -4.13
Confidence Interval (2-Sided) 95%
-5.38 to -2.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.637
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (PBO), Cetirizine (CTZ) 10 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -3.74
Confidence Interval (2-Sided) 95%
-4.99 to -2.49
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.637
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in the MSC Score Over Period II
Hide Description

Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:

Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.

Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Time Frame Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid MSC scores in Period II were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Hide Arm/Group Description:
A single dose of placebo was administered orally on Day 1.
A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Overall Number of Participants Analyzed 76 116 117 119 118
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.50  (0.604) -6.35  (0.489) -7.07  (0.487) -6.78  (0.483) -7.92  (0.485)
3.Secondary Outcome
Title Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II)
Hide Description

Six individual symptoms which are most dominant in the rhinitis symptom profile will be combined to form the MSC severity score:

Runny nose (right and left), itchy nose (right and left), sniffles, nose blows, sneezes, watery eyes.

Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The total MSC score ranges from 0 - 36. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Time Frame Baseline to Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid MSC scores in Period I and II were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Hide Arm/Group Description:
A single dose of placebo was administered orally on Day 1.
A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Overall Number of Participants Analyzed 78 116 119 119 119
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.61  (0.473) -6.80  (0.388) -7.10  (0.383) -7.43  (0.384) -7.72  (0.383)
4.Secondary Outcome
Title Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I
Hide Description

The TSC score was calculated as the sum of the following 10 individual symptom scores:

runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.

Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Time Frame Baseline, Treatment Period I [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid TSC scores in Period I were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Hide Arm/Group Description:
A single dose of placebo was administered orally on Day 1.
A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Overall Number of Participants Analyzed 78 116 119 119 119
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.55  (0.757) -11.33  (0.620) -11.27  (0.613) -12.71  (0.613) -11.74  (0.613)
5.Secondary Outcome
Title Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II
Hide Description

The TSC score was calculated as the sum of the following 10 individual symptom scores:

runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.

Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Time Frame Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid TSC scores in Period II were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Hide Arm/Group Description:
A single dose of placebo was administered orally on Day 1.
A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Overall Number of Participants Analyzed 76 116 117 119 118
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.73  (0.917) -10.25  (0.742) -11.03  (0.739) -10.73  (0.734) -12.14  (0.736)
6.Secondary Outcome
Title Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II)
Hide Description

The TSC score was calculated as the sum of the following 10 individual symptom scores:

runny nose (left and right), itchy nose (left and right), sniffles, nose blows, sneezes, watery eyes, itchy eyes and ears, itchy throat, cough and postnasal drip.

Each individual symptom, except nose blows and sneezes, is rated on a 5-point scale of severity: 0 = None, 1 = a little, 2 = Moderate, 3 = Quite a bit, 4 = severe, 5 = very severe. For nose blows and sneezes, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8. The TSC score ranges from 0 to 56. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Time Frame Baseline to Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid TSC scores in Period I and II were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Hide Arm/Group Description:
A single dose of placebo was administered orally on Day 1.
A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Overall Number of Participants Analyzed 78 116 119 119 119
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.10  (0.729) -10.86  (0.598) -11.22  (0.591) -11.84  (0.591) -11.92  (0.591)
7.Secondary Outcome
Title Change From Baseline in the Individual Symptom Scores Over Period I
Hide Description

Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.

The subjects had to evaluate the severity of the symptoms using a scale from “None” to “Very severe” (ranging from 0 to 5).

For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.

Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Time Frame Baseline, Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only subjects with valid individual symptom scores in Period I were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Hide Arm/Group Description:
A single dose of placebo was administered orally on Day 1.
A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Overall Number of Participants Analyzed 78 116 119 119 119
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Runny Nose Score -0.60  (0.095) -1.01  (0.078) -0.95  (0.077) -1.17  (0.077) -1.04  (0.077)
Itchy Nose Score -0.66  (0.099) -1.03  (0.082) -1.09  (0.081) -1.28  (0.081) -1.10  (0.081)
Sniffles Score -0.65  (0.100) -1.15  (0.082) -1.06  (0.081) -1.24  (0.081) -1.10  (0.081)
Nose Blow Score -0.98  (0.129) -1.87  (0.106) -1.82  (0.105) -1.92  (0.105) -1.96  (0.105)
Sneezes Score -0.37  (0.103) -1.15  (0.084) -1.07  (0.083) -1.22  (0.083) -1.23  (0.083)
Watery Eyes Score -0.56  (0.090) -0.94  (0.074) -1.08  (0.073) -1.13  (0.073) -1.07  (0.073)
8.Secondary Outcome
Title Change From Baseline in the Individual Symptom Scores Over Period II
Hide Description

Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.

The subjects had to evaluate the severity of the symptoms using a scale from “None” to “Very severe” (ranging from 0 to 5).

For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.

Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Time Frame Baseline, Treatment Period II [Day 2, (8:30 am to 12:00 pm)]
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only subjects with valid individual symptom scores in Period II were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Hide Arm/Group Description:
A single dose of placebo was administered orally on Day 1.
A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Overall Number of Participants Analyzed 76 116 117 119 118
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Runny Nose Score -0.62  (0.122) -0.86  (0.098) -0.94  (0.098) -0.95  (0.097) -1.10  (0.098)
Itchy Nose Score -0.57  (0.120) -1.00  (0.097) -1.11  (0.097) -1.13  (0.096) -1.24  (0.096)
Sniffles Score -0.58  (0.127) -0.91  (0.103) -0.96  (0.102) -0.90  (0.101) -1.21  (0.102)
Nose Blow Score -1.00  (0.162) -1.61  (0.131) -1.84  (0.131) -1.78  (0.130) -2.02  (0.130)
Sneezes Score -0.48  (0.112) -1.18  (0.091) -1.33  (0.090) -1.19  (0.089) -1.38  (0.090)
Watery Eyes Score -0.30  (0.119) -0.78  (0.097) -0.91  (0.096) -0.83  (0.096) -0.93  (0.096)
9.Secondary Outcome
Title Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II)
Hide Description

Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Watery Eyes Score, Sneezes Score, Nose Blows Score.

The subjects had to evaluate the severity of the symptoms using a scale from “None” to “Very severe” (ranging from 0 to 5).

For Sneezes Score and Nose Blows Score, the subjects had to record the number of each symptom since last evaluation. This number corresponds to a score ranging from 0 to 8.

Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Time Frame Baseline to Day 2
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only subjects with valid individual symptom scores in Period I and II were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Hide Arm/Group Description:
A single dose of placebo was administered orally on Day 1.
A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1.
A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1.
A single dose of 5 mg of CTZ oral drops was administered orally on Day 1.
A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
Overall Number of Participants Analyzed 78 116 119 119 119
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Runny Nose Score -0.59  (0.093) -0.94  (0.076) -0.95  (0.075) -1.07  (0.075) -1.06  (0.075)
Itchy Nose Score -0.61  (0.097) -1.02  (0.080) -1.10  (0.079) -1.21  (0.079) -1.16  (0.079)
Sniffles Score -0.60  (0.098) -1.05  (0.080) -1.02  (0.079) -1.09  (0.079) -1.15  (0.079)
Nose Blow Score -0.98  (0.124) -1.75  (0.102) -1.83  (0.100) -1.86  (0.101) -1.99  (0.100)
Sneezes Score -0.41  (0.090) -1.17  (0.074) -1.19  (0.073) -1.21  (0.073) -1.31  (0.073)
Watery Eyes Score -0.44  (0.089) -0.87  (0.073) -1.01  (0.072) -1.00  (0.073) -1.01  (0.072)
Time Frame Adverse events were collected from Day 1 until up to 9 days after the study drug intake.
Adverse Event Reporting Description Adverse Events refer to the Safety Population consisting of all subjects who were dispensed medication.
 
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Hide Arm/Group Description A single dose of placebo was administered orally on Day 1. A single dose of 2.5 mg of LCTZ oral drops was administered orally on Day 1. A single dose of 5 mg of LCTZ oral tablet was administered orally on Day 1. A single dose of 5 mg of CTZ oral drops was administered orally on Day 1. A single dose of 10 mg of CTZ oral tablet was administered orally on Day 1.
All-Cause Mortality
Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/116 (0.00%)   0/119 (0.00%)   0/119 (0.00%)   0/119 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/78 (0.00%)   0/116 (0.00%)   0/119 (0.00%)   0/119 (0.00%)   0/119 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo (PBO) Levocetirizine (LCTZ) 2.5 mg Levocetirizine (LCTZ) 5 mg Cetirizine (CTZ) 5 mg Cetirizine (CTZ) 10 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/78 (6.41%)   10/116 (8.62%)   9/119 (7.56%)   13/119 (10.92%)   7/119 (5.88%) 
Cardiac disorders           
Palpitations * 1  0/78 (0.00%)  1/116 (0.86%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
Eye disorders           
Conjunctivitis * 1  0/78 (0.00%)  0/116 (0.00%)  2/119 (1.68%)  0/119 (0.00%)  0/119 (0.00%) 
Ocular hyperaemia * 1  0/78 (0.00%)  0/116 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/119 (0.00%) 
Vision blurred * 1  0/78 (0.00%)  1/116 (0.86%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
Gastrointestinal disorders           
Abdominal discomfort * 1  0/78 (0.00%)  1/116 (0.86%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
Defaecation urgency * 1  0/78 (0.00%)  1/116 (0.86%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
Diarrhoea * 1  0/78 (0.00%)  0/116 (0.00%)  0/119 (0.00%)  1/119 (0.84%)  0/119 (0.00%) 
Dry mouth * 1  0/78 (0.00%)  1/116 (0.86%)  2/119 (1.68%)  3/119 (2.52%)  2/119 (1.68%) 
Flatulence * 1  0/78 (0.00%)  0/116 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/119 (0.00%) 
Nausea * 1  0/78 (0.00%)  1/116 (0.86%)  0/119 (0.00%)  2/119 (1.68%)  0/119 (0.00%) 
Vomiting * 1  0/78 (0.00%)  1/116 (0.86%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
General disorders           
Fatigue * 1  0/78 (0.00%)  0/116 (0.00%)  2/119 (1.68%)  0/119 (0.00%)  1/119 (0.84%) 
Pyrexia * 1  1/78 (1.28%)  0/116 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
Musculoskeletal and connective tissue disorders           
Back pain * 1  0/78 (0.00%)  0/116 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Neck pain * 1  1/78 (1.28%)  0/116 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
Nervous system disorders           
Dizziness * 1  0/78 (0.00%)  0/116 (0.00%)  0/119 (0.00%)  1/119 (0.84%)  0/119 (0.00%) 
Headache * 1  2/78 (2.56%)  2/116 (1.72%)  0/119 (0.00%)  1/119 (0.84%)  2/119 (1.68%) 
Paraesthesia * 1  0/78 (0.00%)  1/116 (0.86%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
Somnolence * 1  0/78 (0.00%)  1/116 (0.86%)  1/119 (0.84%)  1/119 (0.84%)  0/119 (0.00%) 
Syncope vasovagal * 1  0/78 (0.00%)  0/116 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Psychiatric disorders           
Nervousness * 1  0/78 (0.00%)  0/116 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  1/119 (0.84%) 
Respiratory, thoracic and mediastinal disorders           
Dry throat * 1  0/78 (0.00%)  1/116 (0.86%)  0/119 (0.00%)  2/119 (1.68%)  0/119 (0.00%) 
Epistaxis * 1  0/78 (0.00%)  1/116 (0.86%)  1/119 (0.84%)  0/119 (0.00%)  0/119 (0.00%) 
Nasal dryness * 1  0/78 (0.00%)  0/116 (0.00%)  0/119 (0.00%)  1/119 (0.84%)  0/119 (0.00%) 
Nasal mucosal disorder * 1  0/78 (0.00%)  0/116 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/119 (0.00%) 
Pharyngolaryngeal pain * 1  0/78 (0.00%)  0/116 (0.00%)  0/119 (0.00%)  2/119 (1.68%)  1/119 (0.84%) 
Rhinorrhoea * 1  0/78 (0.00%)  0/116 (0.00%)  1/119 (0.84%)  0/119 (0.00%)  0/119 (0.00%) 
Throat tightness * 1  1/78 (1.28%)  0/116 (0.00%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
Skin and subcutaneous tissue disorders           
Periorbital oedema * 1  0/78 (0.00%)  0/116 (0.00%)  0/119 (0.00%)  1/119 (0.84%)  0/119 (0.00%) 
Rash * 1  0/78 (0.00%)  1/116 (0.86%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
Rash maculo-papular * 1  0/78 (0.00%)  1/116 (0.86%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
Rash pruritic * 1  0/78 (0.00%)  1/116 (0.86%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
Swelling face * 1  0/78 (0.00%)  1/116 (0.86%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
Urticaria * 1  0/78 (0.00%)  1/116 (0.86%)  0/119 (0.00%)  0/119 (0.00%)  0/119 (0.00%) 
1
Term from vocabulary, MedDRA
*
Indicates events were collected by non-systematic assessment
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.
Results Point of Contact
Name/Title: UCB
Organization: UCB S.A.
Phone: +1844 599 ext 2273
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00291642     History of Changes
Other Study ID Numbers: A00412
First Submitted: February 10, 2006
First Posted: February 14, 2006
Results First Submitted: October 10, 2017
Results First Posted: July 20, 2018
Last Update Posted: September 11, 2018