Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05529)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Allergic Rhinitis
Intervention: Mometasone furoate nasal spray (MFNS) (Drug); Matching placebo nasal spray (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
Summary
This study seeks to prospectively demonstrate that Nasonex is better than placebo in
relieving nasal congestion in patients with seasonal allergic rhinitis.
Clinical Details
Official title: Placebo-Controlled Study of Mometasone Furoate Nasal Spray (MFNS) 200 mcg QD in the Relief of Nasal Congestion Associated With Seasonal Allergic Rhinitis (SAR)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days
Secondary outcome: The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: August 2008
Last updated: May 27, 2015
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