Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis (Study P05528)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on November 03, 2008
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: Recruiting
Sponsored by: Schering-Plough Overall contact:
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
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: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: The change from Baseline in average AM/PM PRIOR nasal congestion score.
Secondary outcome: The change from Baseline in average AM/PM PRIOR total nasal symptom score.
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
SP Clinical Trial Registry Call Center, Phone: 1-888-772-8734
Investigational Site 6, Oxford, Alabama 36203, United States; Recruiting
Investigational Site 8, Orange, California 92868, United States; Recruiting
Investigational Site 18, Encinitas, California 92024, United States; Recruiting
Investigational Site 25, Long Beach, California 90806-2325, United States; Recruiting
Investigational Site 1, Lawrenceville, Georgia 30045, United States; Recruiting
Investigational Site 24, Woodstock, Georgia 30188, United States; Recruiting
Investigational Site 10, Normal, Illinois 61761, United States; Recruiting
Investigational Site 21, Louisville, Kentucky 40215, United States; Recruiting
Investigational Site 14, Wheaton, Maryland 20902, United States; Recruiting
Investigational Site 12, Novi, Michigan 48375, United States; Recruiting
Investigational Site 22, Omaha, Nebraska 68130, United States; Recruiting
Investigational Site 5, Cincinnati, Ohio 45242, United States; Recruiting
Investigational Site 19, Oklahoma City, Oklahoma 73120, United States; Recruiting
Investigational Site 3, Upland, Pennsylvania 19013, United States; Recruiting
Investigational Site 4, Philadelphia, Pennsylvania 19115, United States; Recruiting
Investigational Site 15, Collegeville, Pennsylvania 19426, United States; Recruiting
Investigational Site 23, Bethlehem, Pennsylvania 18020, United States; Recruiting
Investigational Site 20, Charleston, South Carolina 29407, United States; Recruiting
Investigational Site 7, Fort Worth, Texas 76132, United States; Recruiting
Investigational Site 9, Kerrville, Texas 78006, United States; Recruiting
Investigational Site 11, San Antonio, Texas 78229, United States; Recruiting
Investigational Site 13, Dallas, Texas 75231, United States; Recruiting
Investigational Site 16, San Antonio, Texas 78229, United States; Recruiting
Investigational Site 17, Milwaukee, Wisconsin 53209-0998, United States; Recruiting
Additional Information
Starting date: July 2008
Ending date: November 2008
Last updated: October 21, 2008
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