A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)
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|ClinicalTrials.gov Identifier: NCT01165424|
Recruitment Status : Completed
First Posted : July 19, 2010
Results First Posted : January 23, 2012
Last Update Posted : April 14, 2017
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
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.
|Condition or disease||Intervention/treatment||Phase|
|Rhinitis, Allergic, Perennial||Drug: mometasone furoate||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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)|
|Study Start Date :||April 2010|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Experimental: MFNS 50 μg device
MFNS 50 μg spray device. The dose will be as follows:
Drug: mometasone furoate
MFNS 50 μg spray device
Other Name: Nasonex
Primary Outcome Measures :
- Number of Participants With Adverse Events and Adverse Drug Reactions [ Time Frame: Baseline to Week 24 ]
Secondary Outcome Measures :
- Change From Baseline in the Total Nasal Symptom Score [ Time Frame: Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation) ]Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms.
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