Trials / Completed
CompletedNCT00794144
Safety and Pharmacokinetics of Patanase in Pediatric Patients 2 to < 6 Years of Age
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 132 (actual)
- Sponsor
- Alcon Research · Industry
- Sex
- All
- Age
- 2 Years – 5 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of the study is to assess the safety of the study drug, Patanase (Olopatadine Hydrochloride Nasal Spray 0.6%) compared to placebo (inactive substance) in children ages 2 to less than 6 who have a history of nasal allergies, and to assess the pharmcokinetics (study of the action of a drug in the body) in these children
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Olopatadine Hydrochloride Nasal Spray 0.6% | one spray in each nostril twice daily for 2 weeks |
| DRUG | Olopatadine Hydrochloride Nasal Spray Vehicle | one spray in each nostril twice daily for 2 weeks |
Timeline
- Start date
- 2008-10-01
- Primary completion
- 2008-12-01
- First posted
- 2008-11-19
- Last updated
- 2010-03-04
- Results posted
- 2010-02-04
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00794144. Inclusion in this directory is not an endorsement.