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Safety and PK of Montelukast in Japanese Pediatric PAR
NCT01852812Phase 3
Key facts
- Status
- Completed
- Start
- Jun 2013
- Primary completion
- Dec 2013
- Sponsor
- Organon & Co.
- Modality
- Small Molecules
- Drugs
- montelukast
- Conditions
- perennial allergic rhinitis (PAR)
01
Overview
Phase 3, open-label trial of montelukast in perennial allergic rhinitis (PAR) (3 arms), sponsored by Organon & Co. Primary endpoints: Percentage of Participants Who Experience at Least One Adverse Event (AE) at 14 weeks, Percentage of Participants Who Discontinue Study Drug Due to an AE at 12 weeks and 4 more. Started Jun 2013; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
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)
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
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
03
Who it enrols
Japanese pediatric subjects (1-15 years) with Perennial Allergic Rhinitis, weight >= 8 kg. Excludes patients with asthma, active rhinitis/sinusitis, recent immunotherapy, or uncontrolled hypertension.
04
Endpoints
Primary
Percentage of Participants Who Experience at Least One Adverse Event (AE)
Percentage of Participants Who Discontinue Study Drug Due to an AE
Area Under the Time-Concentration Curve (AUC 0-∞) of Montelukast CT and Montelukast OG
Maximum Plasma Concentration (Cmax) of Montelukast CT and Montelukast OG
Time to Cmax (Tmax) of Montelukast CT and Montelukast OG
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