A Phase III, Open-Label Clinical Trial to Study the Safety and Pharmacokinetics of MK-0476 in Japanese Pediatric Subjects Aged 1 to 15 Years Old With Perennial Allergic Rhinitis
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Organon and Co
- Enrollment
- 87
- Primary Endpoint
- Time to Cmax (Tmax) of Montelukast CT and Montelukast OG
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Montelukast 4 mg OG/1-5 year olds
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)
Intervention: Montelukast Oral Granules (OG) (Drug)
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
Intervention: Montelukast Chewable Tablets (CT) (Drug)
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
Intervention: Montelukast Chewable Tablets (CT) (Drug)
Outcomes
Primary Outcomes
Time to Cmax (Tmax) of Montelukast CT and Montelukast OG
Time Frame: 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.
Percentage of Participants Who Experience at Least One Adverse Event (AE)
Time Frame: 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.
Percentage of Participants Who Discontinue Study Drug Due to an AE
Time Frame: 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.
Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG
Time Frame: 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.
Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG
Time Frame: 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.
Apparent Elimination Half-life (t1/2) of Montelukast CT and Montelukast OG
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported