Phase 3
Completed N=87
Study of the Safety and Pharmacokinetics of Montelukast (MK-0476) in the Treatment of Japanese Pediatric Participants With Perennial Allergic Rhinitis (MK-0476-520)
Perennial Allergic Rhinitis
Source: ClinicalTrials.gov NCT01852812 ↗
Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Sep 2014
Primary outcomePrimary: Percentage of Participants Who Experience at Least One Adverse Event (AE) — 74.5; 55.6 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Experience at Least One Adverse Event (AE) |
74.5; 55.6 | — |
| PRIMARY Percentage of Participants Who Discontinue Study Drug Due to an AE |
0.0; 2.8 | — |
| PRIMARY Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG |
4300; 4350; 3500 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG |
510; 438; 344 | — |
| PRIMARY Time to Cmax (Tmax) of Montelukast CT and Montelukast OG |
2.74; 3.55; 3.65 | — |
| PRIMARY Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG |
1.27; 2.01; 2.08 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01852812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.