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Trial record 1 of 1 for:    NCT00295022
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Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects

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ClinicalTrials.gov Identifier: NCT00295022
Recruitment Status : Completed
First Posted : February 22, 2006
Results First Posted : July 23, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB S.A. - Pharma Sector )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Rhinitis, Allergic, Seasonal
Interventions Drug: Placebo
Drug: Montelukast
Drug: Levocetirizine
Enrollment 418
Recruitment Details  
Pre-assignment Details Participant Flow refers to the Randomized Set.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description Placebo was administered orally on Days 1 and 2. 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2. 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Period Title: Overall Study
Started 105 157 156
Completed 104 156 151
Not Completed 1 1 5
Reason Not Completed
Adverse Event             1             1             2
Lost to Follow-up             0             0             1
Withdrawal by Subject             0             0             2
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT) Total Title
Hide Arm/Group Description Placebo was administered orally on Days 1 and 2. 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2. 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2. [Not Specified]
Overall Number of Baseline Participants 105 157 156 418
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 105 participants 157 participants 156 participants 418 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
104
  99.0%
155
  98.7%
156
 100.0%
415
  99.3%
>=65 years
1
   1.0%
2
   1.3%
0
   0.0%
3
   0.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 105 participants 157 participants 156 participants 418 participants
35.41  (11.74) 34.95  (11.98) 32.98  (11.72) 34.33  (11.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 105 participants 157 participants 156 participants 418 participants
Female
60
  57.1%
101
  64.3%
89
  57.1%
250
  59.8%
Male
45
  42.9%
56
  35.7%
67
  42.9%
168
  40.2%
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)]
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy variables were analyzed using the Intention-To-Treat (ITT) population. ITT consists of all randomized subjects who took at least one dose of study medication.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.46  (0.49) -6.58  (0.40) -5.65  (0.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (PBO), Levocetirizine (LCTZ)
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 -3.12
Confidence Interval (2-Sided) 95%
-4.35 to -1.88
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Levocetirizine (LCTZ), Montelukast (MLKT)
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 -0.93
Confidence Interval (2-Sided) 95%
-2.04 to 0.18
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (PBO), Montelukast (MLKT)
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 Median Difference (Final Values)
Estimated Value -2.19
Confidence Interval (2-Sided) 95%
-3.43 to -0.95
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, from 9:30 am to 11:00 am]
Hide 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) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 104 156 151
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-1.22  (0.52) -6.35  (0.42) -3.24  (0.43)
3.Secondary Outcome
Title Change From Baseline in the MSC Score Over Period III
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 III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid MSC scores in Period III were included in the analysis.
Arm/Group Title Placebo (PBO) Montelukast (MLKT) Levocetirizine (LCTZ)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 104 151 156
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.50  (0.58) -8.62  (0.47) -6.19  (0.48)
4.Secondary Outcome
Title Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III)
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
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid MSC scores during the Total Treatment Period were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.16  (0.46) -7.37  (0.38) -5.48  (0.38)
5.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 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Hide 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) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.16  (0.75) -10.53  (0.61) -9.01  (0.61)
6.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, from 9:30 am to 11:00 am]
Hide 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) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 104 156 151
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.45  (0.76) -9.54  (0.62) -5.12  (0.63)
7.Secondary Outcome
Title Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III
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 III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid TSC scores in Period III were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 104 156 151
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.91  (0.88) -13.39  (0.72) -9.73  (0.73)
8.Secondary Outcome
Title Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III)
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
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid TSC scores during the Total Treatment Period were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.53  (0.72) -11.54  (0.59) -8.68  (0.59)
9.Secondary Outcome
Title Change From Baseline in the TSC Score + Nasal Congestion 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. 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)]
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid TSC score + Nasal congestion score in Period I were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.57  (0.80) -11.15  (0.66) -9.65  (0.66)
10.Secondary Outcome
Title Change From Baseline in the TSC Score + Nasal Congestion 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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Time Frame Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid TSC score + Nasal congestion score in Period II were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 104 156 151
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.65  (0.80) -9.97  (0.65) -5.47  (0.66)
11.Secondary Outcome
Title Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III
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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Time Frame Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid TSC score + Nasal congestion score in Period III were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 104 156 151
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-6.35  (0.94) -14.18  (0.77) -10.39  (0.78)
12.Secondary Outcome
Title Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III)
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 Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril. The TSC score plus Nasal congestion score was added and ranged from 0 to 60. Increasing scores are associated with increasing severity. Negative values indicate improvement from Baseline.

Time Frame Baseline to Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid TSC score + Nasal congestion score during the Total Treatment Period were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-5.92  (0.77) -12.21  (0.63) -9.28  (0.63)
13.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, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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.

The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.

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)]
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid individual symptom scores in Period I were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Runny Nose Score -0.55  (0.09) -0.89  (0.07) -0.86  (0.07)
Itchy Nose Score -0.52  (0.09) -0.93  (0.08) -0.85  (0.08)
Sniffles Score -0.53  (0.09) -0.93  (0.08) -0.87  (0.08)
Postnasal Drip Score -0.65  (0.10) -0.99  (0.08) -0.89  (0.08)
Watery Eyes Score -0.58  (0.09) -0.94  (0.07) -0.82  (0.07)
Itchy Eyes/Ears Score -0.69  (0.09) -1.14  (0.08) -0.90  (0.08)
Itchy Throat Score -0.66  (0.09) -1.00  (0.07) -0.85  (0.07)
Cough Score -0.71  (0.06) -0.81  (0.05) -0.71  (0.05)
Sneezes Score -0.28  (0.11) -1.07  (0.09) -0.68  (0.09)
Nose Blows Score -1.03  (0.13) -1.77  (0.10) -1.59  (0.10)
Nasal Congestion Score -0.41  (0.07) -0.62  (0.06) -0.64  (0.06)
14.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, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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.

The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.

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

Time Frame Baseline, Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid individual symptom scores in Period II were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 104 156 151
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Runny Nose Score -0.18  (0.09) -0.85  (0.08) -0.53  (0.08)
Itchy Nose Score -0.22  (0.09) -0.84  (0.07) -0.40  (0.08)
Sniffles Score -0.10  (0.09) -0.83  (0.08) -0.48  (0.08)
Postnasal Drip Score -0.37  (0.09) -0.90  (0.08) -0.52  (0.08)
Watery Eyes Score -0.20  (0.11) -0.66  (0.09) -0.46  (0.09)
Itchy Eyes/Ears Score -0.18  (0.10) -0.81  (0.08) -0.40  (0.09)
Itchy Throat Score -0.19  (0.10) -0.78  (0.08) -0.39  (0.09)
Cough Score -0.49  (0.08) -0.70  (0.06) -0.58  (0.06)
Sneezes Score -0.19  (0.14) -1.28  (0.11) -0.40  (0.12)
Nose Blows Score -0.38  (0.15) -1.84  (0.13) -0.99  (0.13)
Nasal Congestion Score -0.19  (0.07) -0.43  (0.05) -0.35  (0.06)
15.Secondary Outcome
Title Change From Baseline in the Individual Symptom Scores Over Period III
Hide Description

Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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.

The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.

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

Time Frame Baseline, Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid individual symptom scores in Period III were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 104 156 151
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Runny Nose Score -0.52  (0.11) -1.23  (0.09) -0.93  (0.09)
Itchy Nose Score -0.47  (0.11) -1.25  (0.09) -0.89  (0.09)
Sniffles Score -0.50  (0.11) -1.26  (0.09) -0.96  (0.09)
Postnasal Drip Score -0.67  (0.11) -1.32  (0.09) -0.97  (0.09)
Watery Eyes Score -0.36  (0.11) -1.11  (0.09) -0.84  (0.09)
Itchy Eyes/Ears Score -0.42  (0.12) -1.34  (0.10) -0.87  (0.10)
Itchy Throat Score -0.54  (0.11) -1.15  (0.09) -0.86  (0.09)
Cough Score -0.78  (0.07) -0.97  (0.06) -0.84  (0.06)
Sneezes Score -0.48  (0.12) -1.40  (0.10) -0.78  (0.10)
Nose Blows Score -1.22  (0.15) -2.32  (0.12) -1.82  (0.13)
Nasal Congestion Score -0.43  (0.08) -0.79  (0.06) -0.67  (0.07)
16.Secondary Outcome
Title Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III)
Hide Description

Individual symptom scores include Runny Nose Score, Itchy Nose Score, Sniffles Score, Postnasal Drip Score, Watery Eyes Score, Itchy Eyes and Ears Score, Itchy Throat Score, Cough Score, Sneezes Score, Nose Blows Score, Nasal Congestion 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.

The Nasal congestion score ranged from 0 to 4 (0 = clear, 1 = slight block, 2 = stuffy, 3 = very stuffy, 4 = blocked). It corresponds to the mean value of right nostril and left nostril.

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

Time Frame Baseline to Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Only patients with valid individual symptom scores during the Total Treatment Period were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Runny Nose Score -0.48  (0.09) -1.02  (0.07) -0.84  (0.07)
Itchy Nose Score -0.46  (0.09) -1.05  (0.07) -0.79  (0.07)
Sniffles Score -0.45  (0.09) -1.05  (0.07) -0.85  (0.07)
Postnasal Drip Score -0.62  (0.09) -1.11  (0.07) -0.87  (0.07)
Watery Eyes Score -0.44  (0.09) -0.97  (0.07) -0.77  (0.07)
Itchy Eyes/Ears Score -0.51  (0.10) -1.17  (0.08) -0.81  (0.08)
Itchy Throat Score -0.54  (0.09) -1.03  (0.07) -0.78  (0.07)
Cough Score -0.71  (0.06) -0.86  (0.05) -0.74  (0.05)
Sneezes Score -0.35  (0.10) -1.23  (0.08) -0.67  (0.08)
Nose Blows Score -1.02  (0.12) -2.00  (0.10) -1.58  (0.10)
Nasal Congestion Score -0.38  (0.07) -0.67  (0.05) -0.61  (0.05)
17.Secondary Outcome
Title Time to First Feeling of Improvement During Period I
Hide Description During Period I, the subjects had to record the moment (hh:mm) of first feeling of improvement (compared to Baseline intensity of symptoms).
Time Frame During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects with no first feeling of improvement were censored at 300 minutes.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 66 135 127
Median (95% Confidence Interval)
Unit of Measure: minutes
101.02
(73.02 to 178.02)
70.02
(59.02 to 77.02)
63.02
(60.02 to 73.02)
18.Secondary Outcome
Title Onset of Action During Period I
Hide Description The onset of action was defined as the first time point during Period I after initiation of the treatment when the reduction from Baseline in the MSC score for the active treatment group became statistically different from the placebo group and when this significant change was maintained for some period of time.
Time Frame During Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Measure Type: Number
Unit of Measure: hours
NA [1]  1.5 1.5
[1]
Not applicable for this arm.
19.Secondary Outcome
Title Intensity of Action From Baseline in the MSC Score Over Period I
Hide Description The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period I. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.
Time Frame Treatment Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Measure Type: Number
Unit of Measure: percentage of participants
< 20% 54.3 21.0 32.7
>= 20% 45.7 79.0 67.3
< 50% 80.0 68.8 67.9
>= 50% 20.0 31.2 32.1
< 70% 95.2 87.9 92.3
>= 70% 4.8 12.1 7.7
20.Secondary Outcome
Title Intensity of Action From Baseline in the MSC Score Over Period II
Hide Description The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period II. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.
Time Frame Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Measure Type: Number
Unit of Measure: percentage of participants
< 20% 67.3 32.1 53.6
>= 20% 32.7 67.9 46.4
< 50% 93.3 63.5 87.4
>= 50% 6.7 36.5 12.6
< 70% 98.1 83.3 95.4
>= 70% 1.9 16.7 4.6
21.Secondary Outcome
Title Intensity of Action From Baseline in the MSC Score Over Period III
Hide Description The intensity of action was measured by the percentage of subjects with categorized percentage change from Baseline in the MSC score over Period III. Categories are defined as following: < 20%, >=20%, < 50%, >=50%, < 70%, >=70% change from Baseline.
Time Frame Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Measure Type: Number
Unit of Measure: percentage of participants
< 20% 48.1 16.7 31.8
>= 20% 51.9 83.3 68.2
< 50% 84.6 48.1 63.6
>= 50% 15.4 51.9 36.4
< 70% 89.4 69.9 86.1
>= 70% 10.6 30.1 13.9
22.Secondary Outcome
Title Variability of Action From Baseline in the MSC Score Over Period I
Hide Description

The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:

< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%.

Time Frame Period 1 [Day 1, from drug intake (at 11:00 am) to 5 hours post-treatment (at 4:00 pm)]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Measure Type: Number
Unit of Measure: percentage of participants
< 20% 54.3 21.0 32.7
20%-35% 15.2 22.9 19.2
35%-50% 10.5 24.8 16.0
50%-65% 12.4 12.7 20.5
65%-80% 4.8 15.3 8.3
>=80% 2.9 3.2 3.2
23.Secondary Outcome
Title Variability of Action From Baseline in the MSC Score Over Period II
Hide Description

The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:

< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%.

Time Frame Treatment Period II [Day 2, from 9:30 am to 11:00 am]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Measure Type: Number
Unit of Measure: percentage of participants
< 20% 67.3 32.1 53.6
20%-35% 17.3 19.2 16.6
35%-50% 8.7 12.2 17.2
50%-65% 3.8 17.3 6.6
65%-80% 1.9 10.3 3.3
>=80% 1.0 9.0 2.6
24.Secondary Outcome
Title Variability of Action From Baseline in the MSC Score Over Period III
Hide Description

The variability of action was assessed by the percentage of distribution of the percentage change from Baseline in the MSC score. Categories are defined as following:

< 20%, 20%-35%, 35%-50%, 50%-65%, 65%-80%, >=80%.

Time Frame Treatment Period III [Day 2, from drug intake (at 11:00 am) to 3:30 pm]
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 105 157 156
Measure Type: Number
Unit of Measure: percentage of participants
< 20% 48.1 16.7 31.8
20%-35% 21.2 17.9 14.6
35%-50% 15.4 13.5 17.2
50%-65% 3.8 14.1 17.2
65%-80% 8.7 17.9 14.6
>=80% 2.9 19.9 4.6
25.Secondary Outcome
Title Global Satisfaction of the Subjects at the End of Period III
Hide Description Global satisfaction was evaluated at the end of Period III by the subject on a Visual Analog Scale (VAS) ranging from 0 (very dissatisfied) to 100 mm (very satisfied).
Time Frame At the end of Period III (Day 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with valid data for Global Satisfaction (VAS Score) were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 104 156 152
Mean (Standard Deviation)
Unit of Measure: units on a scale
32.42  (31.05) 53.94  (32.95) 41.80  (32.10)
26.Secondary Outcome
Title Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season
Hide Description At the end of Period III, each subject without reference to the Symptom Diary Card (SDC) answered to the question: "Do you want to take the same treatment during the next pollen season?" (yes or no).
Time Frame At the end of Period III (Day 2)
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects with valid data were included in the analysis.
Arm/Group Title Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Hide Arm/Group Description:
Placebo was administered orally on Days 1 and 2.
5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2.
10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
Overall Number of Participants Analyzed 104 156 152
Measure Type: Number
Unit of Measure: percentage of participants
23.1 49.4 32.9
Time Frame Adverse events were recorded in Study Phase II and in Study Phase III (Day 1 and Day 2), before and after each pollen exposure.
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) Montelukast (MLKT)
Hide Arm/Group Description Placebo was administered orally on Days 1 and 2. 5 mg of Levocetirizine (LCTZ) was administered orally on Days 1 and 2. 10 mg of Montelukast (MLKT) was administered orally on Days 1 and 2.
All-Cause Mortality
Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/105 (0.00%)   0/157 (0.00%)   0/156 (0.00%) 
Hide Serious Adverse Events
Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/105 (0.00%)   0/157 (0.00%)   0/156 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo (PBO) Levocetirizine (LCTZ) Montelukast (MLKT)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   9/105 (8.57%)   13/157 (8.28%)   18/156 (11.54%) 
Ear and labyrinth disorders       
Ear pain  0/105 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Eye disorders       
Conjunctivitis  0/105 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Eye pruritus  0/105 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Eye swelling  0/105 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Ocular hyperaemia  0/105 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Gastrointestinal disorders       
Abdominal pain upper  0/105 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Diarrhoea  0/105 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Nausea  0/105 (0.00%)  1/157 (0.64%)  3/156 (1.92%) 
Vomiting  0/105 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
General disorders       
Fatigue  0/105 (0.00%)  2/157 (1.27%)  0/156 (0.00%) 
Feeling hot  0/105 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Infections and infestations       
Cellulitis  1/105 (0.95%)  0/157 (0.00%)  0/156 (0.00%) 
Conjunctivitis bacterial  0/105 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Upper respiratory tract infection  1/105 (0.95%)  1/157 (0.64%)  0/156 (0.00%) 
Investigations       
Blood pressure increased  0/105 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Body temperature increased  1/105 (0.95%)  0/157 (0.00%)  0/156 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1/105 (0.95%)  0/157 (0.00%)  0/156 (0.00%) 
Musculoskeletal stiffness  1/105 (0.95%)  1/157 (0.64%)  0/156 (0.00%) 
Nodule on extremity  1/105 (0.95%)  0/157 (0.00%)  0/156 (0.00%) 
Nervous system disorders       
Headache  2/105 (1.90%)  0/157 (0.00%)  5/156 (3.21%) 
Sinus headache  0/105 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Somnolence  0/105 (0.00%)  2/157 (1.27%)  1/156 (0.64%) 
Psychiatric disorders       
Anxiety  0/105 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Renal and urinary disorders       
Pollakiuria  0/105 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Respiratory, thoracic and mediastinal disorders       
Cough  0/105 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Dry throat  0/105 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Pharyngolaryngeal pain  1/105 (0.95%)  0/157 (0.00%)  0/156 (0.00%) 
Skin and subcutaneous tissue disorders       
Skin lesion  0/105 (0.00%)  1/157 (0.64%)  0/156 (0.00%) 
Urticaria  1/105 (0.95%)  1/157 (0.64%)  3/156 (1.92%) 
Urticaria localised  0/105 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
Vascular disorders       
Flushing  0/105 (0.00%)  0/157 (0.00%)  1/156 (0.64%) 
1
Term from vocabulary, MedDRA
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
Layout table for Results Point of Contact information
Name/Title: UCB
Organization: Cares
Phone: +1844 599 ext 2273
EMail: UCBCares@ucb.com
Layout table for additonal information
Responsible Party: UCB Pharma ( UCB S.A. - Pharma Sector )
ClinicalTrials.gov Identifier: NCT00295022    
Other Study ID Numbers: A00414
First Submitted: February 20, 2006
First Posted: February 22, 2006
Results First Submitted: October 10, 2017
Results First Posted: July 23, 2018
Last Update Posted: September 11, 2018