Official Title: “Study of Nasonex® (Mometasone Furoate Nasal Spray) for the Treatment of Nasal Polyps in Pediatric Subjects 6 to <18 Years of Age”

The purpose of this study is to evaluate the safety and efficacy of Nasonex® (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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Study Primary Completion Date: June 2008

Intervention(s) in this Clinical Trial

• Drug: mometasone furoate nasal spray
  • One spray of MFNS in each nostril (ie, 100 mcg) once daily for 4 months.
• Drug: mometasone furoate nasal spray
  • One spray of MFNS in each nostril (ie, 100 mcg) twice daily for 4 months.
• Drug: Placebo nasal spray
  • One spray of placebo nasal spray in each nostril once daily for 4 months.
• Drug: Placebo nasal spray
  • One spray of placebo nasal spray in each nostril twice daily for 4 months.
• Drug: mometasone furoate nasal spray
  • Two sprays of MFNS in each nostril (ie, 200 mcg) once daily for 4 months.
• Drug: mometasone furoate nasal spray
  • Two sprays of MFNS in each nostril (ie, 200 mcg) twice daily for 4 months.
• Drug: Placebo nasal spray
  • Two sprays of placebo nasal spray in each nostril once daily for 4 months.
• Drug: Placebo nasal spray
  • Two sprays of placebo nasal spray in each nostril twice daily for 4 months.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: MFNS 100 mcg QD for subjects 6 to less than 12 years of age
• Experimental: MFNS 100 mcg BID for subjects 6 to less than 12 years of age
• Placebo Comparator: Placebo QD for subjects 6 to less than 12 years of age
• Placebo Comparator: Placebo BID for subjects 6 to less than 12 years of age
• Experimental: MFNS 200 mcg QD for subjects 12 to less than 18 years of age
• Experimental: MFNS 200 mcg BID for subjects 12 to less than 18 years of age
• Placebo Comparator: Placebo QD for subjects 12 to less than 18 years of age
• Placebo Comparator: Placebo BID for subjects 12 to less than 18 years of age

Primary Measures

• 24-hour urinary free cortisol level
  • Time Frame: 4 months of treatment
    Safety Issue?: Yes

Secondary Measures

• 24-hour urinary free cortisol level corrected for creatinine
  • Time Frame: 4 months of treatment
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 17 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Schering-Plough

Overall Clinical Trial Officials and Contacts

Ariel Teper, MD Study Director Schering-Plough  

Information obtained from ClinicalTrials.gov on August 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00378378

Study ID Number: P04292

ClinicalTrials.gov Identifier: NCT00378378

Health Authority: United States: Food and Drug Administration