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Montelukast Safety and PK in Infants with Bronchiolitis
NCT00394069Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2003
- Primary completion
- Dec 2003
- Sponsor
- Organon & Co.
- Modality
- Small Molecules
- Drugs
- montelukast
- Conditions
- bronchiolitis
01
Overview
Phase 2, randomised trial of montelukast in bronchiolitis, sponsored by Organon & Co. Primary endpoint: Safety and tolerability of montelukast oral granules at 14 days. Started Jul 2003; status: completed.
02
Design
1 arm- Study design
- Randomized
Montelukast sodium
Participants receive montelukast sodium for 14 days.
03
Who it enrols
Infants aged 3 to 6 months with active bronchiolitis or a history of bronchiolitis and asthma-like symptoms.
04
Endpoints
Primary
Safety and tolerability of montelukast oral granules
Secondary
Single-dose population pharmacokinetics
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