Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years old. Safety will be the primary focus of this study.

Official Title
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Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old

Conditions
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Nasal Polyps

Intervention / Treatment
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* Drug: Mometasone Furoate Nasal Spray (MFNS)
* Drug: Placebo nasal spray


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A subject must be 6 to <18 years of age, of either sex, and of any race. A subject must have a diagnosis of bilateral nasal polyps. A subject must have a minimum nasal congestion/obstruction An asthmatic subject may be included. A subject's clinical laboratory tests (hematology, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. The subject and parent/guardian must be willing to give written informed consent, and the subject must be able to adhere to dose and visit schedules. A female subject of child-bearing potential who is sexually active must have been using a medically accepted method of contraception prior to Screening and must continue using it while receiving protocol-specified medication. If a pre-menarche female subject begins menstruating during the study, a serum pregnancy test must be done at the next visit Exclusion Criteria: A subject with antrochoanal polyps. A subject with cystic fibrosis. A subject with acute sinusitis, concurrent upper respiratory tract infection, or who had an upper respiratory tract infection within 2 weeks prior to the Screening Visit. A subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. A subject who is immunocompromised. A subject with ongoing rhinitis medicamentosa. A subject with Churg Strauss syndrome. A subject with dyskinetic ciliary syndromes, eg, Young's syndrome (sinopulmonary infections and obstructive azoospermia) or Kartagener's syndrome (immotile cilia). A subject with any clinically significant pretreatment laboratory, vital sign, or ECG abnormality. A subject with allergy/sensitivity to aspirin, corticosteroids, or study drug or its excipients. A subject who has not observed the medication washout times outlined in the protocol prior to the Screening Visit. A female subject who is breast-feeding, pregnant, or intends to become pregnant. A subject who has used any investigational drug within 30 days of Screening. A subject who is part of the staff personnel directly involved with this study.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MFNS 100 mcg QD for subjects 6 to less than 12 years<br>Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age | Drug: Mometasone Furoate Nasal Spray (MFNS)<br>* 100 mcg nasal spray<br>* Other names: Nasonex;|
| Placebo Comparator: Placebo QD for subjects 6 to less than 12 years<br> | Drug: Placebo nasal spray<br>* One spray of placebo nasal spray in each nostril once daily for 4 months.<br>|
| Experimental: MFNS 200 mcg QD for subjects 12 to less than 18 years<br> | Drug: Mometasone Furoate Nasal Spray (MFNS)<br>* 100 mcg nasal spray<br>* Other names: Nasonex;|
| Experimental: MFNS 200 mcg BID for subjects 12 to less than 18 years<br> | Drug: Mometasone Furoate Nasal Spray (MFNS)<br>* 100 mcg nasal spray<br>* Other names: Nasonex;|
| Placebo Comparator: Placebo QD for subjects 12 to less than 18 years<br> | Drug: Placebo nasal spray<br>* One spray of placebo nasal spray in each nostril once daily for 4 months.<br>|
| Experimental: MFNS 100 mcg BID for subjects 6 to less than 12 years<br> | Drug: Mometasone Furoate Nasal Spray (MFNS)<br>* 100 mcg nasal spray<br>* Other names: Nasonex;|
| Placebo Comparator: Placebo BID for subjects 6 to less than 12 years<br> | Drug: Placebo nasal spray<br>* One spray of placebo nasal spray in each nostril once daily for 4 months.<br>|
| Placebo Comparator: Placebo BID for subjects 12 to less than 18 years<br> | Drug: Placebo nasal spray<br>* One spray of placebo nasal spray in each nostril once daily for 4 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline 24-hour Urinary Free Cortisol Level | The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to <18 years of age. Primary safety was to be assessed by determining the subject's 24-hour urinary free cortisol level. | Baseline to Endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine | The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine). | Baseline to Endpoint |