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Trial record 4 of 66 for:    Levocetirizine

Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics

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ClinicalTrials.gov Identifier: NCT01563081
Recruitment Status : Completed
First Posted : March 26, 2012
Results First Posted : June 3, 2013
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Rhinitis
Intervention Drug: Levocetirizine
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Levocetirizine: >=6 Months and <12 Months Old Levocetirizine: >=12 Months and <24 Months Old
Hide Arm/Group Description Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks. Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
Period Title: Overall Study
Started 30 30
Completed 30 30
Not Completed 0 0
Arm/Group Title Levocetirizine: >=6 Months and <12 Months Old Levocetirizine: >=12 Months and <24 Months Old Total
Hide Arm/Group Description Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks. Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks. Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Months
Number Analyzed 30 participants 30 participants 60 participants
8.1  (1.94) 15.8  (2.56) 12.0  (4.46)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
11
  36.7%
17
  56.7%
28
  46.7%
Male
19
  63.3%
13
  43.3%
32
  53.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Asian - Japanese Heritage 30 29 59
Asian - Mixed Race 0 1 1
Number of participants with the indicated primary disease at Baseline  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Allergic rhinitis 10 10 20
Pruritus associated with the skin diseases 20 20 40
1.Primary Outcome
Title Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)
Hide Description A non-serious AE is defined as any untoward medical occurrence in a participant/clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse, or misuse. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, or is a possible drug-induced liver injury. For a list of all SAEs/non-serious AEs occurring at a frequency of >=5%, please see the SAE/non-serious AE module of this record.
Time Frame up to Week 2/Early Withdrawal (EW)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population : all participants who participated in this study and who received at least one dose of medication
Arm/Group Title Levocetirizine: >=6 Months and <12 Months Old Levocetirizine: >=12 Months and <24 Months Old Levocetirizine: Total Population
Hide Arm/Group Description:
Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
Overall Number of Participants Analyzed 30 30 60
Measure Type: Number
Unit of Measure: participants
Any Adverse Event 15 17 32
Any Serious Adverse Event 0 0 0
2.Secondary Outcome
Title Number of Participants With the Indicated Change From the First Day of Treatment in Allergic Rhinitis and Pruritis Associated With Skin Diseases at Weeks 1 and 2/EW, as Assessed by the Investigator/Sub-investigator Based on Legal Representative Impression
Hide Description The investigator or sub-investigator made an overall assessment of nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by asking the participants' legal representatives to provide feedback using the following scale: 1, significantly improved; 2, moderately improved; 3, mildly improved; 4, no change; 5, mildly worse; 6, moderately worse; 7, significantly worse. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2. The "n"s in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline.
Time Frame First day of treatment; Weeks 1 and 2/Early Withdrawal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): all participants, excluding those with any major good clinical practice deviation, those who did not meet the primary criteria for enrollment, those who received no dose of study medication, and those with no data after supply of the investigational product
Arm/Group Title Levocetirizine: Total Population
Hide Arm/Group Description:
Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
AR, Week 1, significantly improved, n=20 4
AR, Week 2/EW, significantly improved, n=20 8
AR, Week 1, moderately improved, n=20 5
AR, Week 2/EW, moderately improved, n=20 5
AR, Week 1, mildly improved, n=20 4
AR, Week 2/EW, mildly improved, n=20 5
AR, Week 1, no change, n=20 7
AR, Week 2/EW, no change, n=20 1
AR, Week 1, mildly worse, n=20 0
AR, Week 2/EW, mildly worse, n=20 0
AR, Week 1, moderately worse, n=20 0
AR, Week 2/EW, moderately worse, n=20 1
AR, Week 1, significantly worse, n=20 0
AR, Week 2/EW, significantly worse, n=20 0
PAWSD, Week 1, significantly improved, n=40 4
PAWSD, Week 2/EW, significantly improved, n=40 6
PAWSD, Week 1, moderately improved, n=40 11
PAWSD, Week 2/EW, moderately improved, n=40 16
PAWSD, Week 1, mildly improved, n=40 13
PAWSD, Week 2/EW, mildly improved, n=40 14
PAWSD, Week 1, no change, n=40 12
PAWSD, Week 2/EW, no change, n=40 4
PAWSD, Week 1, mildly worse, n=40 0
PAWSD, Week 2/EW, mildly worse, n=40 0
PAWSD, Week 1, moderately worse, n=40 0
PAWSD, Week 2/EW, moderately worse, n=40 0
PAWSD, Week 1, significantly worse, n=40 0
PAWSD, Week 2/EW, significantly worse, n=40 0
3.Secondary Outcome
Title Number of Participants With the Indicated Change From the First Day of Treatment in Nasal Symptoms and Pruritis Associated With Skin Diseases at Weeks 1 and 2/Early Withdrawal, as Assessed by the Investigator or Sub-investigator
Hide Description The investigator or sub-investigator comprehensively assessed the participants' improvement in nasal symptoms (allergic rhinitis [AR]) and pruritus associated with skin diseases (PAWSD) at Weeks 1 and 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) compared to the first day of treatment by using the following scale: 1, markedly improved; 2, moderately improved; 3, slightly improved; 4, no change; 5, worsened.
Time Frame First day of treatment; Weeks 1 and 2/Early Withdrawal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants with AR and PAWSD at Baseline were assessed for improvement in the conditions at Weeks 1 and 2/Early Withdrawal. The "n"s in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline.
Arm/Group Title Levocetrizine: Total Population
Hide Arm/Group Description:
Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
Overall Number of Participants Analyzed 60
Measure Type: Number
Unit of Measure: participants
AR, Week 1, markedly improved, n=20 7
AR, Week 2/EW, markedly improved, n=20 12
AR, Week moderately improved, n=20 4
AR, Week 2/EW, moderately improved, n=20 3
AR, Week 1, slightly improved, n=20 3
AR, Week 2/EW, slightly improved, n=20 4
AR, Week 1, no change, n=20 6
AR, Week 2/EW, no change, n=20 1
AR, Week 1, worsened, n=20 0
AR, Week 2/EW, worsened, n=20 0
PAWSD, Week 1, markedly improved, n=40 6
PAWSD, Week 2/EW, markedly improved, n=40 10
PAWSD, Week 1, moderately improved, n=40 15
PAWSD, Week 2/EW, moderately improved, n=40 19
PAWSD, Week 1, slightly improved, n=40 12
PAWSD, Week 2/EW, slightly improved, n=40 8
PAWSD, Week 1, no change, n=40 7
PAWSD, Week 2/EW, no change, n=40 3
PAWSD, Week 1, worsened, n=40 0
PAWSD, Week 2/EW, worsened, n=40 0
4.Secondary Outcome
Title Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal
Hide Description The investigator comprehensively assessed the pariticipant’s severity of pruritus on the first day of treatment (FDOT), at Week 1, and at Week 2 (or at the discontinuation day in the case of early withdrawal [EW] from the clinical trial) by using the following scale: 4, severe; 3, moderate; 2, mild; 1, slight; 0, none.
Time Frame First day of treatment; Weeks 1 and 2/Early Withdrawal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
FAS. Only those participants with pruritis associated with skin diseases at Baseline were assessed for pruritis severity.
Arm/Group Title Levocetrizine: Total Population
Hide Arm/Group Description:
Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: participants
FDOT, none 0
FDOT, slight 7
FDOT, mild 17
FDOT, moderate 11
FDOT, severe 5
Week 1, none 6
Week 1, slight 14
Week 1, mild 11
Week 1, moderate 7
Week 1, severe 2
Week 2/EW, none 13
Week 2/EW, slight 8
Week 2/EW, mild 11
Week 2/EW, moderate 8
Week 2/EW, severe 0
5.Secondary Outcome
Title Cmax and Cmin of Levocetirizine in Plasma
Hide Description Cmax is defined as the peak plasma concentration of a drug after administration. Cmin is defined as the lowest (trough) concentration that a drug reaches before the next dose is administered. For both age cohorts, blood samples were collected 1.5-2.5 hours after the last drug administration for assessment of Cmax at either Week 1 or 2/EW. For participants in the >=6 months and <12 months cohort, blood samples were collected 22.5-25.5 hours after the last drug administration for Cmin at a different visit from Cmax sampling. For participants in the >=12 months and <24 months cohort, blood samples were collected 10.5-13.5 hours after the final drug administration for Cmin at a different visit from Cmax sampling. For all participants, if Cmin sampling occurred at Week 1, then Cmax sampling occurred at Week 2/EW, and vice versa.
Time Frame Weeks 1 and 2/Early Withdrawal
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Pharmacokinetic Concentration Population: all participants who underwent blood sampling, who provided data at the time of the last dose and the time of blood sampling, and who provided valid drug concentrations
Arm/Group Title Levocetirizine: >=6 Months and <12 Months Old Levocetirizine: >=12 Months and <24 Months Old
Hide Arm/Group Description:
Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
Overall Number of Participants Analyzed 30 30
Median (Full Range)
Unit of Measure: nanograms per milliliter
Cmax
206.780
(41.89 to 327.03)
213.440
(17.75 to 323.42)
Cmin
17.710
(3.49 to 104.46)
48.330
(2.91 to 126.18)
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from the start of the study up to Week 2/Early Withdrawal.
Adverse Event Reporting Description SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who received at least one dose of study medication.
 
Arm/Group Title Levocetirizine: >=6 Months and <12 Months Old Levocetirizine: >=12 Months and <24 Months Old Levocetirizine: Total Population
Hide Arm/Group Description Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks. Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks. Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
All-Cause Mortality
Levocetirizine: >=6 Months and <12 Months Old Levocetirizine: >=12 Months and <24 Months Old Levocetirizine: Total Population
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Levocetirizine: >=6 Months and <12 Months Old Levocetirizine: >=12 Months and <24 Months Old Levocetirizine: Total Population
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%)   0/60 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Levocetirizine: >=6 Months and <12 Months Old Levocetirizine: >=12 Months and <24 Months Old Levocetirizine: Total Population
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   7/30 (23.33%)   12/30 (40.00%)   19/60 (31.67%) 
Gastrointestinal disorders       
Diarrhoea  1  2/30 (6.67%)  2/30 (6.67%)  4/60 (6.67%) 
Infections and infestations       
Nasopharyngitis  1  0/30 (0.00%)  7/30 (23.33%)  7/60 (11.67%) 
Gastroenteritis  1  1/30 (3.33%)  2/30 (6.67%)  3/60 (5.00%) 
Respiratory, thoracic and mediastinal disorders       
Pharyngeal erythema  1  3/30 (10.00%)  0/30 (0.00%)  3/60 (5.00%) 
Skin and subcutaneous tissue disorders       
Eczema  1  2/30 (6.67%)  1/30 (3.33%)  3/60 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA, version 15.0
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01563081     History of Changes
Other Study ID Numbers: 116455
First Submitted: March 15, 2012
First Posted: March 26, 2012
Results First Submitted: March 7, 2013
Results First Posted: June 3, 2013
Last Update Posted: February 28, 2017