Rhinitis
Conditions
Keywords
Allergic rhinitis, Pediatric, Pruritus, Levocetirizine
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).
Interventions
DRUGLevocetirizine
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
Sponsors
GlaxoSmithKline
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 23 Months
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) | up to Week 2/Early Withdrawal (EW) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | First day of treatment; Weeks 1 and 2/Early Withdrawal | 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 ns in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline. |
| 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 | First day of treatment; Weeks 1 and 2/Early Withdrawal | 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. |
| Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | First day of treatment; Weeks 1 and 2/Early Withdrawal | 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. |
| Cmax and Cmin of Levocetirizine in Plasma | Weeks 1 and 2/Early Withdrawal | 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. |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Levocetirizine: >=6 Months and <12 Months Old | Levocetirizine: >=12 Months and <24 Months Old | Total |
|---|---|---|---|
| Age, Continuous | 8.1 Months STANDARD_DEVIATION 1.94 | 15.8 Months STANDARD_DEVIATION 2.56 | 12.0 Months STANDARD_DEVIATION 4.46 |
| Gender Female | 11 Participants | 17 Participants | 28 Participants |
| Gender Male | 19 Participants | 13 Participants | 32 Participants |
| Number of participants with the indicated primary disease at Baseline Allergic rhinitis | 10 participants | 10 participants | 20 participants |
| Number of participants with the indicated primary disease at Baseline Pruritus associated with the skin diseases | 20 participants | 20 participants | 40 participants |
| Race/Ethnicity, Customized Asian - Japanese Heritage | 30 Participants | 29 Participants | 59 Participants |
| Race/Ethnicity, Customized Asian - Mixed Race | 0 Participants | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 7 / 30 | 12 / 30 | 19 / 60 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 | 0 / 60 |
Outcome results
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.
Time frame: up to Week 2/Early Withdrawal (EW)
Population: Safety Population : all participants who participated in this study and who received at least one dose of medication
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) | Any Adverse Event | 15 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) | Any Serious Adverse Event | 0 participants |
| Levocetirizine: >=12 Months and <24 Months Old | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) | Any Adverse Event | 17 participants |
| Levocetirizine: >=12 Months and <24 Months Old | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) | Any Serious Adverse Event | 0 participants |
| Levocetirizine: Total Population | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) | Any Serious Adverse Event | 0 participants |
| Levocetirizine: Total Population | Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) | Any Adverse Event | 32 participants |
Secondary
Cmax and Cmin of Levocetirizine in Plasma
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
Population: 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 | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Levocetirizine: >=6 Months and <12 Months Old | Cmax and Cmin of Levocetirizine in Plasma | Cmin | 17.710 nanograms per milliliter |
| Levocetirizine: >=6 Months and <12 Months Old | Cmax and Cmin of Levocetirizine in Plasma | Cmax | 206.780 nanograms per milliliter |
| Levocetirizine: >=12 Months and <24 Months Old | Cmax and Cmin of Levocetirizine in Plasma | Cmax | 213.440 nanograms per milliliter |
| Levocetirizine: >=12 Months and <24 Months Old | Cmax and Cmin of Levocetirizine in Plasma | Cmin | 48.330 nanograms per milliliter |
Secondary
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal
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
Population: FAS. Only those participants with pruritis associated with skin diseases at Baseline were assessed for pruritis severity.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | FDOT, slight | 7 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | FDOT, mild | 17 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | FDOT, moderate | 11 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | FDOT, severe | 5 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | Week 1, moderate | 7 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | Week 1, severe | 2 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | Week 2/EW, none | 13 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | Week 2/EW, slight | 8 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | Week 2/EW, mild | 11 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | FDOT, none | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | Week 1, none | 6 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | Week 1, slight | 14 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | Week 1, mild | 11 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | Week 2/EW, moderate | 8 participants |
| Levocetirizine: >=6 Months and <12 Months Old | Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal | Week 2/EW, severe | 0 participants |
Secondary
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 ns 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
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 2/EW, significantly improved, n=20 | 8 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 1, moderately improved, n=20 | 5 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 2/EW, moderately improved, n=20 | 5 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 1, mildly improved, n=20 | 4 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 2/EW, mildly improved, n=20 | 5 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 1, no change, n=20 | 7 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 2/EW, no change, n=20 | 1 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 2/EW, moderately worse, n=20 | 1 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 1, significantly worse, n=20 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 2/EW, significantly worse, n=20 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 1, significantly improved, n=40 | 4 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 2/EW, significantly improved, n=40 | 6 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 1, moderately improved, n=40 | 11 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 2/EW, moderately improved, n=40 | 16 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 1, mildly improved, n=40 | 13 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 2/EW, mildly improved, n=40 | 14 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 1, no change, n=40 | 12 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 1, mildly worse, n=40 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 2/EW, mildly worse, n=40 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 1, moderately worse, n=40 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 2/EW, moderately worse, n=40 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 1, significantly worse, n=40 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 1, significantly improved, n=20 | 4 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 1, mildly worse, n=20 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 2/EW, mildly worse, n=20 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 1, moderately worse, n=20 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 2/EW, significantly worse, n=40 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 2/EW, no change, n=40 | 4 participants |
Secondary
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
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
Population: 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 ns in the category titles reflect the number of participants in the Full Analysis Set (FAS) who had AR and PAWSD at Baseline.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 1, markedly improved, n=40 | 6 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 1, no change, n=40 | 7 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 2/EW, no change, n=40 | 3 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 1, markedly improved, n=20 | 7 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 2/EW, markedly improved, n=20 | 12 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week moderately improved, n=20 | 4 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 2/EW, moderately improved, n=20 | 3 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 1, slightly improved, n=20 | 3 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 2/EW, slightly improved, n=20 | 4 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 1, no change, n=20 | 6 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 2/EW, no change, n=20 | 1 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 1, worsened, n=20 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | AR, Week 2/EW, worsened, n=20 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 2/EW, markedly improved, n=40 | 10 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 1, moderately improved, n=40 | 15 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 2/EW, moderately improved, n=40 | 19 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 1, slightly improved, n=40 | 12 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 2/EW, slightly improved, n=40 | 8 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 1, worsened, n=40 | 0 participants |
| Levocetirizine: >=6 Months and <12 Months Old | 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 | PAWSD, Week 2/EW, worsened, n=40 | 0 participants |