Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)
CompletedPhase 3Results postedLast updated 18 June 2024
What this trial tests
Phase 3 trial testing Montelukast Oral Granules (OG) in Perennial Allergic Rhinitis in 87 participants. Completed in 24 December 2013.
Adults 1 to 15, any sex, with Perennial Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants Who Experience at Least One Adverse Event (AE)Primary· Up to 14 days after last dose of study drug (Up to 14 weeks)
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.
Group
Value
95% CI
Montelukast 4 mg OG/1-5 Year Olds
74.5
Montelukast 5 mg CT/6-15 Year Olds
55.6
Percentage of Participants Who Discontinue Study Drug Due to an AEPrimary· Up to 12 weeks
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.
Group
Value
95% CI
Montelukast 4 mg OG/1-5 Year Olds
0.0
Montelukast 5 mg CT/6-15 Year Olds
2.8
Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OGPrimary· Up to Day 28 after first dose of study drug
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.
Group
Value
95% CI
Montelukast 4 mg OG/1-5 Year Olds
4300
± 800
Montelukast 5 mg CT/6-9 Year Olds
4350
± 760
Montelukast 5 mg CT/10-15 Year Olds
3500
± 620
Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OGPrimary· Up to Day 28 after first dose of study drug
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.
Group
Value
95% CI
Montelukast 4 mg OG/1-5 Year Olds
510
± 84
Montelukast 5 mg CT/6-9 Year Olds
438
± 82
Montelukast 5 mg CT/10-15 Year Olds
344
± 61
Time to Cmax (Tmax) of Montelukast CT and Montelukast OGPrimary· Up to Day 28 after first dose of study drug
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.
Group
Value
95% CI
Montelukast 4 mg OG/1-5 Year Olds
2.74
± 0.60
Montelukast 5 mg CT/6-9 Year Olds
3.55
± 0.71
Montelukast 5 mg CT/10-15 Year Olds
3.65
± 0.60
Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OGPrimary· Up to Day 28 after first dose of study drug
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.
Group
Value
95% CI
Montelukast 4 mg OG/1-5 Year Olds
1.27
± 0.56
Montelukast 5 mg CT/6-9 Year Olds
2.01
± 0.75
Montelukast 5 mg CT/10-15 Year Olds
2.08
± 0.66
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 14 days after last dose of study drug (Up to 14 weeks).
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Organon and Co
Last refreshed: 18 June 2024
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