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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

Page last updated: August 23, 2015

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