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| ID | Type | Description | Link |
|---|---|---|---|
| 132233 | Registry Identifier | JAPIC-CTI |
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This study will evaluate the safety and pharmacokinetics of montelukast (MK-0476) in the treatment of Japanese pediatric participants with perennial allergic rhinitis (PAR). The primary hypothesis of this study is that montelukast oral granules (OG) and chewable tablets (CT) provide appropriate exposure to montelukast in Japanese pediatric participants with PAR.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast 4 mg OG/1-5 year olds | Experimental | Participants receive montelukast 4 mg OG in one sachet orally (PO) once daily (QD) at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total) |
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| Montelukast 5 mg CT/6-9 year olds | Experimental | Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks |
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| Montelukast 5 mg CT/10-15 year olds | Experimental | Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast Oral Granules (OG) | Drug | Montelukast 4 mg in one sachet |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience at Least One Adverse Event (AE) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Participants were monitored for the occurrence of AEs for up to 14 days after last dose of study drug (up to a total of 14 weeks). AEs were reported based on the dose of study drug participants received. | Up to 14 days after last dose of study drug (Up to 14 weeks) |
| Percentage of Participants Who Discontinue Study Drug Due to an AE | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Discontinuations due to an AE were reported based on the dose of study drug participants received. | Up to 12 weeks |
| Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG | Blood samples for pharmacokinetic (PK) assessments were collected at either 1 hour (h) or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28. | Up to Day 28 after first dose of study drug |
| Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG | Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28. | Up to Day 28 after first dose of study drug |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27785374 | Result | Okubo K, Inoue Y, Numaguchi H, Tanaka K, Saito I, Oshima N, Matsumoto Y, Prohn M, Mehta A, Nishida C, Philip G. Montelukast in the treatment of perennial allergic rhinitis in paediatric Japanese patients; an open-label clinical trial. J Drug Assess. 2016 Sep 19;5(1):6-14. doi: 10.1080/21556660.2016.1209507. eCollection 2016. | |
| 30027002 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Montelukast 4 mg OG/1-5 Year Olds | Participants receive montelukast 4 mg oral granules (OG) in one sachet orally (PO) once daily (QD) at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total) |
| FG001 | Montelukast 5 mg CT/6-9 Year Olds |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Montelukast Chewable Tablets (CT) |
| Drug |
Montelukast 5 mg in one tablet |
|
| Time to Cmax (Tmax) of Montelukast CT and Montelukast OG |
Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28. |
| Up to Day 28 after first dose of study drug |
| Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG | Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28. | Up to Day 28 after first dose of study drug |
| Hashiguchi K, Okubo K, Inoue Y, Numaguchi H, Tanaka K, Oshima N, Mehta A, Nishida C, Saito I, Philip G. Evaluation of Montelukast for the Treatment of Children With Japanese Cedar Pollinosis Using an Artificial Exposure Chamber (OHIO Chamber). Allergy Rhinol (Providence). 2018 Jul 13;9:2152656718783599. doi: 10.1177/2152656718783599. eCollection 2018 Jan-Dec. |
Participants receive montelukast 5 mg chewable tablets (CT) in one tablet PO QD at bed time for 12 weeks |
| FG002 | Montelukast 5 mg CT/10-15 Year Olds | Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Montelukast 4 mg OG/1-5 Year Olds | Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total) |
| BG001 | Montelukast 5 mg CT/6-9 Year Olds | Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks |
| BG002 | Montelukast 5 mg CT/10-15 Year Olds | Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percentage of Participants Who Experience at Least One Adverse Event (AE) | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Participants were monitored for the occurrence of AEs for up to 14 days after last dose of study drug (up to a total of 14 weeks). AEs were reported based on the dose of study drug participants received. | The All Subjects as Treated (ASaT) population consisted of all participants who received at least one dose of study drug. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses. | Posted | Number | Percentage of participants | Up to 14 days after last dose of study drug (Up to 14 weeks) |
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| Primary | Percentage of Participants Who Discontinue Study Drug Due to an AE | An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a pre-existing condition that is temporally associated with the use of study drug is also an AE. Discontinuations due to an AE were reported based on the dose of study drug participants received. | The ASaT population consisted of all participants who received at least one dose of study drug. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses. | Posted | Number | Percentage of participants | Up to 12 weeks |
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| Primary | Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG | Blood samples for pharmacokinetic (PK) assessments were collected at either 1 hour (h) or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28. | The All Subjects Pharmacokinetically Evaluable (ASPE) population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group. | Posted | Mean | Standard Deviation | h*ng/mL | Up to Day 28 after first dose of study drug |
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| Primary | Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG | Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28. | The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group. | Posted | Mean | Standard Deviation | ng/mL | Up to Day 28 after first dose of study drug |
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| Primary | Time to Cmax (Tmax) of Montelukast CT and Montelukast OG | Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28. | The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group. | Posted | Mean | Standard Deviation | Hours | Up to Day 28 after first dose of study drug |
| ||||||||||||||||||||||||||||||
| Primary | Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG | Blood samples for PK assessments were collected at either 1 h or 3 h post-dose on Day 1 and at either 14 h or 22 h post-dose on Day 28. | The ASPE population consisted of all participants from the ASaT population who had an evaluable assessement for this PK parameter and did not have any protocol violation which would interfere with this PK parameter. Data for PK assessments were reported by dose of study drug received and age group. | Posted | Mean | Standard Deviation | Hours | Up to Day 28 after first dose of study drug |
|
Up to 14 days after last dose of study drug (Up to 14 weeks)
The ASaT population consisted of all participants who received at least one dose of study drug. AEs were reported based on the dose of study drug participants received. Data from the two montelukast 5 mg CT groups (6-9 year olds and 10-15 year olds) were pooled for safety analyses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Montelukast 4 mg OG/1-5 Year Olds | Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total) | 0 | 51 | 37 | 51 | ||
| EG001 | Montelukast 5 mg CT/6-15 Year Olds | Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks | 0 | 36 | 18 | 36 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Acute sinusitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Otitis media acute | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA 16.1 | Systematic Assessment |
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| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 16.1 | Systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Systematic Assessment |
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| Miliaria | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Systematic Assessment |
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The sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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