Trials / Completed
CompletedNCT01857063
Study of the Efficacy and Safety of MK-0476 in Japanese Pediatric Participants With Seasonal Allergic Rhinitis (MK-0476-519)
A Phase III, Double-Blind, Randomized, Placebo-Controlled Cross-over Clinical Trial to Study the Efficacy and Safety of MK-0476 in Japanese Pediatric Subjects With Seasonal Allergic Rhinitis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 220 (actual)
- Sponsor
- Organon and Co · Industry
- Sex
- All
- Age
- 10 Years – 15 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the efficacy and safety of montelukast (MK-0476) in the treatment of Japanese pediatric participants with seasonal allergic rhinitis (SAR). The primary hypothesis of this study is that montelukast is superior to placebo in the treatment of nasal symptoms in SAR.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Montelukast | Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days |
| DRUG | Placebo | Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days |
Timeline
- Start date
- 2013-06-10
- Primary completion
- 2013-09-01
- Completion
- 2013-09-01
- First posted
- 2013-05-20
- Last updated
- 2024-06-17
- Results posted
- 2014-05-26
Source: ClinicalTrials.gov record NCT01857063. Inclusion in this directory is not an endorsement.