RhinitisPhase 3NCT01563081
Safety Study of Levocetirizine Oral Solution for Japanese Pediatrics
A Phase 3 study testing Levocetirizine in people with Rhinitis, run by GlaxoSmithKline at 7 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 23 months
- Conditions the study is for
- Rhinitis
- What is being tested?
- Levocetirizine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 7 sitesJapan
- Study dates
- Apr 2012to Aug 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 23 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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"
Show all 17Show fewer
- 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)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
GSK Investigational Site
Chiba, 260-0001
GSK Investigational Site
Tokyo, 136-0073
GSK Investigational Site
Tokyo, 154-0002
GSK Investigational Site
Tokyo, 154-0017
GSK Investigational Site
Tokyo, 157-0066
GSK Investigational Site
Tokyo, 158-0094
GSK Investigational Site
Tokyo, 176-0012
About this study
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.
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.
Read the 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).
- Conditions
- Rhinitis
- Being tested
- Levocetirizine
- Keywords
- Allergic rhinitis, Pediatric, Pruritus, Levocetirizine
- Medical subject headings
- Rhinitis, Rhinitis, Allergic, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevocetirizineDrug
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
LevocetirizineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Levocetirizine | Experimental | Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution Receives: Drug: Levocetirizine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to Week 2/Early Withdrawal (EW)
Secondary outcomes (4)
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.
Measured: First day of treatment; Weeks 1 and 2/Early Withdrawal
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.
Measured: First day of treatment; Weeks 1 and 2/Early Withdrawal
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.
Measured: First day of treatment; Weeks 1 and 2/Early Withdrawal
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.
Measured: Weeks 1 and 2/Early Withdrawal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RhinitisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563081
- Sponsor's protocol ID
- 116455
- Status last verified
- Jan 2017
- First submitted
- 15 Mar 2012
- Last updated
- 28 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01563081
- Acronym / sponsor ID
- 116455
- Conditions
- Rhinitis
- Keywords
- Allergic rhinitis, Pediatric, Pruritus, Levocetirizine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Posted 3 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Levocetirizine | Experimental | Drug: LevocetirizineClear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution |
Who may qualify
- Ages
- 6 to 23 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.)
Key exclusion criteria (17 listed)
- 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.]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevocetirizineClear 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 |
| LevocetirizineClear 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 | Drug | Levocetirizine |
Primary outcome
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs)
Time frame: 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.
4 secondary outcomes
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
Time frame: First day of treatment; Weeks 1 and 2/Early Withdrawal
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
Time frame: First day of treatment; Weeks 1 and 2/Early Withdrawal
Number of Participants Categorized With the Indicated Pruritis Severity on the First Day of Treatment and at Weeks 1 and 2/Early Withdrawal
Time frame: First day of treatment; Weeks 1 and 2/Early Withdrawal
Cmax and Cmin of Levocetirizine in Plasma
Time frame: Weeks 1 and 2/Early Withdrawal
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levocetirizine in people with Rhinitis, run by GlaxoSmithKline at 7 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Serious Adverse Events (SAEs) and Non-serious Adverse Events (AEs) (time frame: up to Week 2/Early Withdrawal (EW)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017.