Status:
COMPLETED
Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)(COMPLETED)
Lead Sponsor:
Organon and Co
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.
Eligibility Criteria
Inclusion
- A subject must be 12 years of age or older, of either sex, and of any race.
- A subject must have at least a 2-year history of SAR which exacerbates during the study season.
- A subject must have a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
- A subject must be clinically symptomatic at the Screening and Baseline Visits.
Exclusion
- A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
- A subject who has had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who has had a viral upper respiratory infection within 7 days prior to the Screening Visit.
- A subject who has used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
- A subject who is participating in any other clinical study.
- A subject who is part of the staff personnel directly involved with this study.
- A subject who is a family member (parent, spouse, or sibling) of the investigational study staff.
- A female subject who is breast-feeding, pregnant, or intends to become pregnant.
- A subject previously randomized into this study.
- A subject who has a family member (parent, spouse, or sibling) currently enrolled in this study.
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT00733005
Start Date
July 1 2008
End Date
October 1 2008
Last Update
May 21 2024
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