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Trial record 7 of 66 for:    Levocetirizine

Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 1 to Less Than 6 Years Suffering From Allergic Rhinitis or Chronic Urticaria of Unknown Origin (PAL)

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ClinicalTrials.gov Identifier: NCT00619801
Recruitment Status : Completed
First Posted : February 21, 2008
Results First Posted : September 4, 2009
Last Update Posted : March 6, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Conditions Allergic Rhinitis
Chronic Urticaria
Interventions Drug: Levocetirizine
Drug: Placebo
Enrollment 173
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV). Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Period Title: Overall Study
Started 59 114
Safety Population 59 114
Completed 58 111
Not Completed 1 3
Reason Not Completed
Lack of Efficacy             0             1
Withdrawal by Subject             1             1
Loss of efficacy             0             1
Arm/Group Title Placebo Levocetirizine Total
Hide Arm/Group Description Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV). Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV). Total of all reporting groups
Overall Number of Baseline Participants 59 114 173
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 114 participants 173 participants
<=18 years
59
 100.0%
114
 100.0%
173
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 59 participants 114 participants 173 participants
3.75  (1.45) 3.78  (1.38) 3.77  (1.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 59 participants 114 participants 173 participants
Female
23
  39.0%
49
  43.0%
72
  41.6%
Male
36
  61.0%
65
  57.0%
101
  58.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 59 participants 114 participants 173 participants
59 114 173
1.Primary Outcome
Title Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Ventricular Rate (VR)
Hide Description [Not Specified]
Time Frame Baseline, 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population; only non-missing values were analyzed
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Number of Participants Analyzed 56 110
Mean (Standard Deviation)
Unit of Measure: beats per minute
-1.5  (14.1) 1.3  (14.2)
2.Primary Outcome
Title Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in RR Interval
Hide Description The RR interval refers to the respective time interval in the Electrocardiogram (ECG).
Time Frame Baseline, 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population; only non-missing values were analyzed
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Number of Participants Analyzed 56 110
Mean (Standard Deviation)
Unit of Measure: milliseconds
9.2  (85.9) -6.9  (83.4)
3.Primary Outcome
Title Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in PR Interval
Hide Description The PR interval refers to the respective time interval in the Electrocardiogram (ECG).
Time Frame Baseline, 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population; only non-missing values were analyzed
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Number of Participants Analyzed 56 110
Mean (Standard Deviation)
Unit of Measure: milliseconds
0.5  (9.6) -0.8  (11.0)
4.Primary Outcome
Title Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QRS Duration
Hide Description The QRS duration refers to the respective time duration in the Electrocardiogram (ECG).
Time Frame Baseline, 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population; only non-missing values were analyzed
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Number of Participants Analyzed 56 110
Mean (Standard Deviation)
Unit of Measure: milliseconds
0.3  (6.6) 0.9  (7.1)
5.Primary Outcome
Title Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval
Hide Description The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Time Frame Baseline, 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population; only non-missing values were analyzed
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Number of Participants Analyzed 56 110
Mean (Standard Deviation)
Unit of Measure: milliseconds
-2.8  (17.2) -1.5  (19.2)
6.Primary Outcome
Title Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF)
Hide Description The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Time Frame Baseline, 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population; only non-missing values were analyzed
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Number of Participants Analyzed 56 110
Mean (Standard Deviation)
Unit of Measure: milliseconds
-5.5  (14.3) -0.3  (16.6)
7.Primary Outcome
Title Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 3 (Day 7)
Hide Description The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population; only non-missing values were analyzed
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Number of Participants Analyzed 57 112
Mean (Standard Deviation)
Unit of Measure: milliseconds
372.6  (16.5) 368.9  (19.4)
8.Primary Outcome
Title Absolute Value of QT Interval Corrected for Heart Rate Using Fridericia’s Formula (QTcF) at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV)
Hide Description The QT interval refers to the respective time interval in the Electrocardiogram (ECG).
Time Frame 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population; only non-missing values were analyzed
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Number of Participants Analyzed 57 111
Mean (Standard Deviation)
Unit of Measure: milliseconds
369.8  (17.1) 370.5  (18.5)
9.Secondary Outcome
Title Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Total Bilirubin
Hide Description [Not Specified]
Time Frame Baseline, 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population; only non-missing values were analyzed
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Number of Participants Analyzed 54 104
Median (Full Range)
Unit of Measure: micromole per liter [µmol/L]
0.000
(-10.26 to 3.42)
0.000
(-8.55 to 5.13)
10.Secondary Outcome
Title Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Alanine Aminotransferase (ALT)
Hide Description [Not Specified]
Time Frame Baseline, 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population; only non-missing values were analyzed
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Number of Participants Analyzed 54 105
Median (Full Range)
Unit of Measure: unit per liter [U/L]
-1.5
(-12 to 167)
1.0
(-21 to 138)
11.Secondary Outcome
Title Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminotransferase (AST)
Hide Description [Not Specified]
Time Frame Baseline, 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population; only non-missing values were analyzed
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Number of Participants Analyzed 53 105
Median (Full Range)
Unit of Measure: unit per liter [U/L]
-1.0
(-15 to 52)
1.0
(-16 to 58)
12.Secondary Outcome
Title Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Urea Nitrogen
Hide Description [Not Specified]
Time Frame Baseline, 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population; only non-missing values were analyzed
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Number of Participants Analyzed 54 105
Median (Full Range)
Unit of Measure: millimole per liter [mmol/L]
-0.1785
(-2.142 to 2.142)
0.0000
(-3.570 to 3.213)
13.Secondary Outcome
Title Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Blood Creatinine
Hide Description [Not Specified]
Time Frame Baseline, 14 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population; only non-missing values were analyzed
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description:
Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
Overall Number of Participants Analyzed 54 105
Median (Full Range)
Unit of Measure: micromole per liter [µmol/L]
-0.8840
(-17.680 to 13.260)
1.7680
(-15.912 to 16.796)
Time Frame Adverse Events were collected from Visit 1 (Day -2 to -28) over randomization and On-treatment Period up to the Follow-up Visit (Day 21±2).
Adverse Event Reporting Description Adverse Events refer to the safety population including all subjects who were dispensed study treatment at least once.
 
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV). Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
All-Cause Mortality
Placebo Levocetirizine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Levocetirizine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/59 (0.00%)      1/114 (0.88%)    
General disorders     
Pyrexia * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Levocetirizine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/59 (35.59%)      39/114 (34.21%)    
Cardiac disorders     
Tachycardia * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Ear and labyrinth disorders     
Cerumen impaction * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
Eye disorders     
Eye swelling * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Gastrointestinal disorders     
Diarrhoea * 1  2/59 (3.39%)  2 4/114 (3.51%)  4
Vomiting * 1  2/59 (3.39%)  2 4/114 (3.51%)  4
Teething * 2  1/59 (1.69%)  1 1/114 (0.88%)  1
Eructation * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Constipation * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Abdominal pain upper * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
Salivary hypersecretion * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
Aphthous stomatitis * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
General disorders     
Pyrexia * 1  1/59 (1.69%)  1 5/114 (4.39%)  5
Fatigue * 1  1/59 (1.69%)  1 1/114 (0.88%)  1
Pain * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Hunger * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
Thirst * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
Infections and infestations     
Upper respiratory tract infection * 1  2/59 (3.39%)  2 3/114 (2.63%)  3
Nasopharyngitis * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Sinusitis * 1  2/59 (3.39%)  2 1/114 (0.88%)  1
Otitis media * 1  0/59 (0.00%)  0 3/114 (2.63%)  3
Gastroenteritis viral * 1  1/59 (1.69%)  1 1/114 (0.88%)  1
Viral rash * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Viral upper respiratory tract infection * 1  2/59 (3.39%)  2 1/114 (0.88%)  1
Viral pharyngitis * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
Gastroenteritis * 1  0/59 (0.00%)  0 2/114 (1.75%)  2
Folliculitis * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Hordeolum * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Urinary tract infection * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
Injury, poisoning and procedural complications     
Head injury * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Skin laceration * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Investigations     
Alanine aminotransferase increased * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Metabolism and nutrition disorders     
Anorexia * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
Dehydration * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle spasms * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
Nervous system disorders     
Somnolence * 1  2/59 (3.39%)  2 1/114 (0.88%)  1
Headache * 1  1/59 (1.69%)  1 1/114 (0.88%)  1
Psychomotor hyperactivity * 1  3/59 (5.08%)  3 0/114 (0.00%)  0
Psychiatric disorders     
Sleep disorder * 1  0/59 (0.00%)  0 2/114 (1.75%)  2
Nervousness * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Middle insomnia * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
Restlessness * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Cough * 1  5/59 (8.47%)  6 4/114 (3.51%)  4
Asthma * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Wheezing * 1  1/59 (1.69%)  1 1/114 (0.88%)  1
Epistaxis * 1  1/59 (1.69%)  1 2/114 (1.75%)  2
Nasal discomfort * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Rhinorrhoea * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Respiratory tract congestion * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
Skin and subcutaneous tissue disorders     
Scab * 2  0/59 (0.00%)  0 1/114 (0.88%)  1
Swelling face * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Dermatitis diaper * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Skin irritation * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Rash * 1  0/59 (0.00%)  0 1/114 (0.88%)  2
Urticaria * 1  0/59 (0.00%)  0 1/114 (0.88%)  1
Rash papular * 1  1/59 (1.69%)  1 0/114 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
2
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.
UCB has > 60 days but <= 180 days to review results communications prior to public release and may delete information that compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that results shall be published regardless of outcome.
Results Point of Contact
Name/Title: UCB Clinical Trial Call Center
Organization: UCB
Phone: +1 877 822 9493
Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT00619801     History of Changes
Other Study ID Numbers: A00426
RPCE07K2404
2015-000205-39 ( EudraCT Number )
First Submitted: February 11, 2008
First Posted: February 21, 2008
Results First Submitted: July 28, 2009
Results First Posted: September 4, 2009
Last Update Posted: March 6, 2015