Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics - Full Text View

Purpose

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.

Condition	Intervention	Phase
Rhinitis	Drug: Levoceitirizine Drug: Levocetirizine	Phase 3

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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.

Resource links provided by NLM:

MedlinePlus related topics: Itching Skin Conditions

Drug Information available for: Levocetirizine Levocetirizine dihydrochloride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Incidence of AE [ Time Frame: Week 2 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma levocetirizine concentration [ Time Frame: Week 2 ] [ Designated as safety issue: No ]
Global improvement of rhinitis condition/skin itching [ Time Frame: Week 1 and Week 2 ] [ Designated as safety issue: No ]
Assessing the patient's improvement of rhinitis condition and itching at Week 1 and 2, or at the time of discontinuation comprehensively in five levels (1.Markedly improved, 2.Moderately improved, 3.Slightly improved, 4.No change, 5.Worsened) in comparison with those at the first day of treatment period
Legal representative's impression of rhinitis symptom/skin itching [ Time Frame: Week 1 and Week 2 ] [ Designated as safety issue: No ]
Assessing legal representative's impression for symptoms of the patient with allergic rhinitis or pruritus associated with various skin diseases in comparison with those at the first day of treatment period by inquiring legal representative at Week 1 and 2, or at the time of discontinuation, and determine their symptoms in seven levels (1.Significantly improved, 2.Moderately improved, 3.Mildly improved, 4.No change, 5.Mildly worse, 6.Moderately worse, 7.Significantly worse).

Enrollment:	60
Study Start Date:	April 2012
Study Completion Date:	August 2012
Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Levocetirizine Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution	Drug: Levoceitirizine 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 Drug: Levocetirizine Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution. Levocetirizine oral solution are administered twice daily at a dose of 2.5 mL (1.25 mg of levocetirizine) in the morning and evening before sleep to infants aged between 1 year and 2 years old

Arms

Assigned Interventions

Experimental: Levocetirizine

Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution

Drug: Levoceitirizine

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

Drug: Levocetirizine

Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution. Levocetirizine oral solution are administered twice daily at a dose of 2.5 mL (1.25 mg of levocetirizine) in the morning and evening before sleep to infants aged between 1 year and 2 years old

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

Ages Eligible for Study:	6 Months to 23 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563081

Locations

Japan
GSK Investigational Site
Chiba, Japan, 260-0001
GSK Investigational Site
Tokyo, Japan, 176-0012
GSK Investigational Site
Tokyo, Japan, 154-0002
GSK Investigational Site
Tokyo, Japan, 157-0066
GSK Investigational Site
Tokyo, Japan, 136-0073
GSK Investigational Site
Tokyo, Japan, 154-0017

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01563081 History of Changes
Other Study ID Numbers:	116455
Study First Received:	March 15, 2012
Last Updated:	September 20, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:

Allergic rhinitis
Pediatric
Pruritus
Levocetirizine

Additional relevant MeSH terms:

Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Levocetirizine
Cetirizine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists

Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Anti-Allergic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013