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Trial record 9 of 66 for:    Levocetirizine

Safety Study of Levocetirizine Dihydrochloride Oral Liquid Formulation in Children Aged 6 Months to 11 Months (BALL)

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ClinicalTrials.gov Identifier: NCT00628108
Recruitment Status : Completed
First Posted : March 4, 2008
Results First Posted : October 14, 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 1.25 mg
Other: Placebo
Enrollment 69
Recruitment Details  
Pre-assignment Details One subject was randomized to levocetirizine but received placebo; hence the number of subjects in both treatment groups in the Safety Population differs by 1 from the number of the subjects randomized (STARTED) to the respective treatment group. All results are presented for the safety population for which the subjects were analyzed as treated.
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description Placebo (5 drops) dosed by mouth in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 23 46 [1]
Safety Population 24 45 [2]
Completed 22 43
Not Completed 1 3
Reason Not Completed
Adverse Event             0             3
Withdrawal by Subject             1             0
[1]
One subject was randomized to levocetirizine but received placebo.
[2]
Subjects in the Safety Population were analyzed as treated.
Arm/Group Title Placebo Levocetirizine Total
Hide Arm/Group Description Placebo (5 drops) dosed by mouth in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 24 45 69
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 45 participants 69 participants
<=18 years
24
 100.0%
45
 100.0%
69
 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:  Months
Number Analyzed 24 participants 45 participants 69 participants
9.03  (1.80) 8.87  (1.63) 8.93  (1.67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 45 participants 69 participants
Female
13
  54.2%
17
  37.8%
30
  43.5%
Male
11
  45.8%
28
  62.2%
39
  56.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 45 participants 69 participants
24 45 69
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 in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 20 38
Mean (Standard Deviation)
Unit of Measure: beats per minute
-7.6  (17.3) -4.0  (16.9)
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 in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 20 38
Mean (Standard Deviation)
Unit of Measure: milliseconds
28.0  (63.9) 14.9  (58.4)
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 in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 20 38
Mean (Standard Deviation)
Unit of Measure: milliseconds
0.8  (11.3) 3.1  (11.3)
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 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 in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 20 38
Mean (Standard Deviation)
Unit of Measure: milliseconds
1.4  (6.4) 0.3  (5.7)
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 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 in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 20 38
Mean (Standard Deviation)
Unit of Measure: milliseconds
4.5  (21.1) -0.3  (18.7)
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 in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 20 38
Mean (Standard Deviation)
Unit of Measure: milliseconds
-1.3  (20.9) -3.9  (17.3)
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 in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 21 42
Mean (Standard Deviation)
Unit of Measure: milliseconds
360.3  (15.2) 354.5  (21.1)
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 in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 23 39
Mean (Standard Deviation)
Unit of Measure: milliseconds
355.3  (17.7) 351.9  (18.0)
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 in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 19 35
Median (Full Range)
Unit of Measure: micromole per liter [µmol/L]
0.000
(-1.71 to 1.71)
0.000
(-3.42 to 3.42)
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 in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 19 34
Median (Full Range)
Unit of Measure: unit per liter [U/L]
-2.0
(-27 to 15)
-1.0
(-24 to 41)
11.Secondary Outcome
Title Change From Baseline at Visit 4 (Day 14) or at Early Discontinuation Visit (EDV) in Aspartate Aminontransferase (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 in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 19 34
Median (Full Range)
Unit of Measure: unit per liter [U/L]
2.0
(-15 to 21)
-1.0
(-36 to 23)
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 in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 19 36
Median (Full Range)
Unit of Measure: millimole per liter [mmol/L]
0.0000
(-0.714 to 2.856)
0.0000
(-3.927 to 4.641)
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 in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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 19 36
Median (Full Range)
Unit of Measure: micromole per liter [μmol/L]
-0.8840
(-9.724 to 20.332)
-0.8840
(-18.564 to 10.608)
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 medication at least once.
 
Arm/Group Title Placebo Levocetirizine
Hide Arm/Group Description Placebo (5 drops) dosed by mouth in the morning at breakfast time once 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 oral drops (5 drops containing 5 mg/mL) dosed by mouth in the morning at breakfast time once 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   0/24 (0.00%)      1/45 (2.22%)    
Infections and infestations     
Otitis media acute * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Acute sinusitis * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Upper respiratory tract infection * 1  0/24 (0.00%)  0 1/45 (2.22%)  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   17/24 (70.83%)      29/45 (64.44%)    
Cardiac disorders     
Sinus arrhythmia * 1  1/24 (4.17%)  1 1/45 (2.22%)  1
Sinus bradycardia * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Ear and labyrinth disorders     
Ear pruritus * 1  1/24 (4.17%)  1 0/45 (0.00%)  0
Eye disorders     
Eye discharge * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Gastrointestinal disorders     
Diarrhoea * 1  1/24 (4.17%)  1 6/45 (13.33%)  6
Teething * 1  0/24 (0.00%)  0 3/45 (6.67%)  3
Constipation * 1  1/24 (4.17%)  1 3/45 (6.67%)  3
Vomiting * 1  1/24 (4.17%)  1 2/45 (4.44%)  2
General disorders     
Pyrexia * 1  4/24 (16.67%)  4 7/45 (15.56%)  7
Irritability * 1  3/24 (12.50%)  3 1/45 (2.22%)  1
Thirst * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Injection site pain * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Infections and infestations     
Otitis media * 1  2/24 (8.33%)  3 2/45 (4.44%)  2
Upper respiratory tract infection * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Sinusitis * 1  1/24 (4.17%)  1 0/45 (0.00%)  0
Viral infection * 1  1/24 (4.17%)  1 1/45 (2.22%)  1
Viral upper respiratory tract infection * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Gastroenteritis * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Oral candidiasis * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Bronchitis acute * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Skin infection * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Metabolism and nutrition disorders     
Increased appetite * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Nervous system disorders     
Somnolence * 1  1/24 (4.17%)  1 2/45 (4.44%)  2
Psychiatric disorders     
Insomnia * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders     
Cough * 1  2/24 (8.33%)  3 1/45 (2.22%)  1
Productive cough * 1  1/24 (4.17%)  1 1/45 (2.22%)  1
Rhinorrhoea * 1  1/24 (4.17%)  2 2/45 (4.44%)  2
Asthma * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Wheezing * 1  1/24 (4.17%)  1 0/45 (0.00%)  0
Nasal congestion * 1  1/24 (4.17%)  1 0/45 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis atopic * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Dermatitis contact * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Dermatitis diaper * 1  3/24 (12.50%)  3 1/45 (2.22%)  1
Eczema * 1  1/24 (4.17%)  1 1/45 (2.22%)  1
Hyperkeratosis * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Rash * 1  0/24 (0.00%)  0 1/45 (2.22%)  1
Heat rash * 1  1/24 (4.17%)  1 0/45 (0.00%)  0
Rash papular * 1  2/24 (8.33%)  2 0/45 (0.00%)  0
Pruritus * 1  1/24 (4.17%)  1 0/45 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 9.0
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: NCT00628108     History of Changes
Other Study ID Numbers: A00423
RPCE08K2403
2007-003458-28 ( EudraCT Number )
First Submitted: February 22, 2008
First Posted: March 4, 2008
Results First Submitted: September 9, 2009
Results First Posted: October 14, 2009
Last Update Posted: March 6, 2015