Safety Study of Levocetirizine Oral Solution for Japanese... | NCT01563081

NCT01563081

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Description Module

Label	Type	Description	Intervention Names
Levocetirizine	Experimental	Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution	Drug: Levocetirizine

Name	Type	Description	Arm Group Labels	Other Names
Levocetirizine	Drug	Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution. Levocetirizine oral solution are administered once daily at a dose of 2.5 mL (1.25 mg of levocetirizine) in the morning to infants aged between 6 months and 1 year old

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)	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.	up to Week 2/Early Withdrawal (EW)

Secondary Outcomes

Measure	Description	Time Frame
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	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatients
Either boys or girls are acceptable.
Pediatric patients ranging from 6 months to 2 years in age at the time of initiation of the treatment in clinical trial
Pediatric patients who have at least one of the symptoms associated with allergic rhinitis including rhinorrhea, nasal congestion and sneezing, and require at least 2-week treatment with antihistamine drugs, or those who suffer from pruritus associated with the following diseases and require at least 2-week treatment with antihistamine drugs (- Chronic urticaria, - Eczema/dermatitis group: atopic dermatitis etc. [A diagnosis of atopic dermatitis is made in accordance with the "Definition/Diagnostic Criteria of Atopic Dermatitis, - Prurigo group: acute prurigo (strophulus, urticaria-like lichen, etc.), subacute prurigo, chronic prurigo (nodular prurigo etc.), - Pruritus cutaneous: systemic pruritus cutaneous, local pruritus cutaneous)
Pediatric patients with QTc interval below 450 msec. QTc interval shall be below 480 msec in the pediatric patients with bundle branch block at screening (A judgment shall be made according to the QTc interval based on ECG result corresponding to one heart beat or the QTc interval based on the mean of ECG results corresponding to 3 heart beats.)
AST<2×upper limit of normal, ALT<2×upper limit of normal, alkaline phosphatase≤1.5×upper limit of normal, bilirubin≤1.5×upper limit of normal at screening (The serum bilirubin shall be fractioned and the direct bilirubin shall be below 35%. In this case, the free bilirubin level exceeding 1.5 times the upper limit of normal is acceptable.)
Pediatric patients whose parents (persons with parental authority or guardians) shall submit written informed consent
Pediatric patients whose parents (persons with parental authority or guardians) shall fill the medication diaries

Exclusion Criteria:

Pediatric patients whose body weight is above or below the infantile growth curves shown in the infant body growth investigation report in 2011 [MHLW, 2011]
Pediatric patients breast-fed by mothers who take any antihistamine drugs during the study period
Pediatric patients who received systemic adrenocorticosteroids within 28 days before Visit 2
Pediatric patients who are currently treated or planned to have immunotherapy initiated during the study period
Pediatric patients who had abnormal laboratory results that were unrelated to allergic disorders [These patients can be enrolled if the investigator (or sub-investigator) judges that their enrolment poses no clinical problem.]
Pediatric patients who require application of adrenocorticosteroids for external use that are classified as "strongest," "very strong" or "strong"
Pediatric patients who suffer from asthma as a complication and require treatment with adrenocorticosteroids (including adrenocorticosteroid combinations)
Pediatric patients with the history of convulsion, febrile convulsion or sleep apnea
Pediatric patients whose brothers or sisters have history of sleep apnea or sudden infant death syndrome
Pediatric patients with history of allergy or hypersensitivity to the ingredients of levocetirizine hydrochloride preparation or piperazine derivatives such as hydroxyzine, cetirizine, cyclizine
Pediatric patients with history of drug hypersensitivity
Pediatric patients who are considered inappropriate as the subjects of this clinical trial because of liver diseases, renal diseases, heart diseases or other complications that pose clinical problem
Pediatric patients whose parents are minors
Infants who belong to children's institutions
Pediatric patients who participated in other clinical trials for 6 months before enrolment or those who intend to participate in other clinical trials during the clinical trial period.
Person meeting any of the following criteria and his/her family (- An employee of GlaxoSmithKline K.K., - Investigator or sub-investigator, - An employee of Site Management Organization (SMO) related with the clinical study)
Other pediatric patients who are judged as inappropriate for participating in this clinical trial by the investigator (or sub-investigator)](streamdown:incomplete-link)

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Chiba		260-0001	Japan
GSK Investigational Site

ID	Title	Description
FG000	Levocetirizine: >=6 Months and <12 Months Old	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.
FG001	Levocetirizine: >=12 Months and <24 Months Old	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.

ID	Title	Description
BG000	Levocetirizine: >=6 Months and <12 Months Old	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.
BG001	Levocetirizine: >=12 Months and <24 Months Old

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
Primary	Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)	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.	Safety Population : all participants who participated in this study and who received at least one dose of medication	Posted		Number		participants		up to Week 2/Early Withdrawal (EW)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Levocetirizine: >=6 Months and <12 Months Old	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.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA, version 15.0	Systematic Assessment

Title	Organization	Phone	Extension	Email
GSK Response Center	GlaxoSmithKline	866-435-7343

ID	Term
D012220	Rhinitis
D065631	Rhinitis, Allergic
D011537	Pruritus

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009668	Nose Diseases
D012140	Respiratory Tract Diseases

ID	Term
C472067	levocetirizine

ID	Title	Description
OG000	Levocetirizine: >=6 Months and <12 Months Old	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.
OG001	Levocetirizine: >=12 Months and <24 Months Old	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.
OG002	Levocetirizine: Total Population	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.