Clinical trial NCT01563081: Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics
Official title: A Multi-Center, Open-labelled Study to Evaluate the Safety of Levocetirizine Hydrochloride Oral Solution in Children Aged 6 Months to 2 Years With Allergic Rhinitis or Pruritus Associated With the Skin Diseases.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis
Keywords: Allergic rhinitis
Pediatric
Pruritus
Levocetirizine
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 60
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of treatment with levocetirizine oral solution in pediatric patients aged form 6 months to 2 years old with allergic rhinitis or pruritus associated with the skin diseases.

Detailed description: This is a multi-center, open-labelled study to confirm the safety as main objective, and consisting of minimum 1-week screening period and 2-week treatment period. The subjects who meet the inclusion criteria are to be placed on one of the following two regimens according to their ages at the start of treatment period: once daily administration of levocetirizine at a dose of 1.25 mg (in the morning) to infants aged between 6 months and 1 year old (younger age group), and twice daily administration of levocetirizine at a dose of 1.25 mg (in the morning, in the evening before sleep) to infants aged between 1 year and 2 years old (older age group).

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)

Primary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)
timeFrame: up to Week 2/Early Withdrawal (EW)
Secondary outcomes:
measure: 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
timeFrame: First day of treatment; Weeks 1 and 2/Early Withdrawal
measure: 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
timeFrame: First day of treatment; Weeks 1 and 2/Early Withdrawal
measure: Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal
timeFrame: First day of treatment; Weeks 1 and 2/Early Withdrawal
measure: Cmax and Cmin of Levocetirizine in Plasma
timeFrame: Weeks 1 and 2/Early Withdrawal
Other outcomes:
Locations:
city: Chiba
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: