Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)
Condition: Nasal Polyps
MeSH terms: Nasal Polyps; Polyps
Intervention: Mometasone Furoate Nasal Spray (MFNS); Placebo nasal spray
Intervention description: 100 mcg nasal spray; One spray of placebo nasal spray in each nostril once daily for 4 months.
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 127.0
Sex: All
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.