Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients

Completed · Phase 3

Conditions studied: Seasonal Allergic Rhinitis

In brief

A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6 to 11 years with a history of seasonal allergic rhinitis.

Key facts

Study ID

NCT00578929

Run by

Alcon Research

People needed

2388

Starts

2007-09-01

Last updated by the study team

2010-03-02

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female; minimum of 6 years of age and less than 12 years
• 2 year history of seasonal allergic rhinitis

You may not qualify if…

• Concurrent disease that might interfere with the investigation or evaluation of te study medication
• Confirmed diagnosis of chronic rhinosinusitis within the last year
• Asthma, with the exception of mild intermittent asthma
• Anatomical nasal deformity
• Nasal obstruction
• Known non-responder to antihistamines for symptoms of Seasonal Allergic Rhinitis (SAR)
• Chronic or intermittent use of of inhaled, oral, intramuscular intravenous corticosteroids ot topical steroids
• Ocular disorder other that allergic conjunctivitis

Where it is running

• Kenilworth/IL — Kenilworth, Illinois, United States

Full record on ClinicalTrials.gov

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