Clinical Trial: A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Study of Long-term (12-24 Weeks) Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No. P06333)
Brief Summary: Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the follow-up.
Detailed Summary:
Sponsor: Merck Sharp & Dohme Corp.
Current Primary Outcome: Number of Participants With Adverse Events and Adverse Drug Reactions [ Time Frame: Baseline to Week 24 ]
Original Primary Outcome: Safety measurement based on the number and the incidence of adverse events and adverse drug reactions. [ Time Frame: From week 12 to week 24 continuously for 12 weeks ]
Current Secondary Outcome: Change From Baseline in the Total Nasal Symptom Score [ Time Frame: Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation) ]
Original Secondary Outcome:
Information By: Merck Sharp & Dohme Corp.
Dates:
Date Received: May 28, 2010
Date Started: April 2010
Date Completion:
Last Updated: March 17, 2017
Last Verified: March 2017
