Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05583)

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Mometasone Furoate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.