A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)(COMPLETED)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Schering-Plough

ClinicalTrials.gov Identifier:

NCT01165424

First received: May 28, 2010

Last updated: December 16, 2011

Last verified: December 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 28, 2010
Last Updated Date	December 16, 2011
Start Date ^ICMJE	April 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: December 16, 2011)	Number of Participants With Adverse Events and Adverse Drug Reactions [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: July 16, 2010)	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 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT01165424 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: December 16, 2011)	Change From Baseline in the Total Nasal Symptom Score [ Time Frame: Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation) ] [ Designated as safety issue: No ] 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.
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of Long-term Administration of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06333AM1)(COMPLETED)
Official Title ^ICMJE	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 Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Rhinitis, Allergic, Perennial
Intervention ^ICMJE	Drug: mometasone furoate MFNS 50 μg spray device 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning. 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning. Other Name: Nasonex
Study Arm (s)	Experimental: MFNS 50 μg device MFNS 50 μg spray device. The dose will be as follows: 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning. 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning. Intervention: Drug: mometasone furoate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	80
Completion Date	December 2010
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree. Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust mite antigen). Male or female outpatients aged 3 to 15 years at the time of providing informed consent. Exclusion Criteria: Subjects with coexisting tuberculosis or lower respiratory tract infection, or who have an acute upper respiratory tract infection or acute pharyngolaryngitis, etc. judged by the investigator to require treatment at the time of registration Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics Subjects with repeated epistaxis Subjects with coexisting fungal infection in nasal/sinus cavity Subjects with a history of hypersensitivity to steroids or ingredients of mometasone furoate nasal spray Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor. Subjects allergic to pollen (cedar, Japanese cypress, birch, grasses, mugwort, common ragweed, etc.) for whom the pollen season coincides with the observation period
Gender	Both
Ages	3 Years to 15 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01165424
Other Study ID Numbers ^ICMJE	P06333
Has Data Monitoring Committee	No
Responsible Party	Schering-Plough
Study Sponsor ^ICMJE	Schering-Plough
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Schering-Plough
Verification Date	December 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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