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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01852812
Other study ID # 0476-520
Secondary ID 132233
Status Completed
Phase Phase 3
First received
Last updated
Start date June 7, 2013
Est. completion date December 24, 2013

Study information

Verified date February 2022
Source Organon and Co
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 87
Est. completion date December 24, 2013
Est. primary completion date December 24, 2013
Accepts healthy volunteers No
Gender All
Age group 1 Year to 15 Years
Eligibility Inclusion Criteria: - Weight =8 kg - Diagnosis of PAR and has symptoms of PAR at Visit 1 Exclusion Criteria: - Past or present medical history of asthma - Diagosis of acute rhinitis, simple rhinitis, rhinitis congestive, rhinitis atrophic, sinusitis with purulent nasal discharge, rhinitis medicamentosa or nonallergic rhinitis (e.g. vasomotor rhinitis, eosinophilic rhinitis) - Started hyposensitization therapy or non-specific immunotherapy within 6 months prior to Visit 1 - Medical history of inferior concha mucosal resection, submucous resection of inferior turbinates or other surgery aimed at reduction and/or modulation of nasal mucosa (including electrocoagulation, cryoextraction or application of trichloroacetic acid) - Clinically significant, active disease of the cardiovascular or hematologic systems or uncontrolled hypertension (1 to 5 year olds: >120/70 mmHg; 6 to 9 year olds: >130/80 mmHg; 10 to 15 year olds: >140/85 mmHg) - Medical history of stunted growth - Serious drug allergy - Treated with other clinical study drug within 3 months prior to Visit 1

Study Design


Intervention

Drug:
Montelukast Oral Granules (OG)
Montelukast 4 mg in one sachet
Montelukast Chewable Tablets (CT)
Montelukast 5 mg in one tablet

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Organon and Co

References & Publications (1)

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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
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. Up to 14 days after last dose of study drug (Up to 14 weeks)
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. Up to 12 weeks
Primary Area Under the Time-Concentration Curve (AUC 0-8) 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
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. Up to Day 28 after first dose of study drug
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. 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. Up to Day 28 after first dose of study drug
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