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

NCT ID: NCT00378378

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-06-30

Brief 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.

Conditions

Nasal Polyps

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MFNS 100 mcg QD for subjects 6 to less than 12 years

Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age

Group Type: EXPERIMENTAL

Mometasone Furoate Nasal Spray (MFNS)

Intervention Type: DRUG

100 mcg nasal spray

Placebo QD for subjects 6 to less than 12 years

Group Type: PLACEBO_COMPARATOR

Placebo nasal spray

Intervention Type: DRUG

One spray of placebo nasal spray in each nostril once daily for 4 months.

MFNS 200 mcg QD for subjects 12 to less than 18 years

Group Type: EXPERIMENTAL

Mometasone Furoate Nasal Spray (MFNS)

Intervention Type: DRUG

100 mcg nasal spray

MFNS 200 mcg BID for subjects 12 to less than 18 years

Group Type: EXPERIMENTAL

Mometasone Furoate Nasal Spray (MFNS)

Intervention Type: DRUG

100 mcg nasal spray

Placebo QD for subjects 12 to less than 18 years

Group Type: PLACEBO_COMPARATOR

Placebo nasal spray

Intervention Type: DRUG

One spray of placebo nasal spray in each nostril once daily for 4 months.

MFNS 100 mcg BID for subjects 6 to less than 12 years

Group Type: EXPERIMENTAL

Mometasone Furoate Nasal Spray (MFNS)

Intervention Type: DRUG

100 mcg nasal spray

Placebo BID for subjects 6 to less than 12 years

Group Type: PLACEBO_COMPARATOR

Placebo nasal spray

Intervention Type: DRUG

One spray of placebo nasal spray in each nostril once daily for 4 months.

Placebo BID for subjects 12 to less than 18 years

Group Type: PLACEBO_COMPARATOR

Placebo nasal spray

Intervention Type: DRUG

One spray of placebo nasal spray in each nostril once daily for 4 months.

Interventions

Mometasone Furoate Nasal Spray (MFNS)

100 mcg nasal spray

Intervention Type: DRUG

Placebo nasal spray

One spray of placebo nasal spray in each nostril once daily for 4 months.

Intervention Type: DRUG

Other Intervention Names

Nasonex

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Chur V, Small CB, Stryszak P, Teper A. Safety of mometasone furoate nasal spray in the treatment of nasal polyps in children. Pediatr Allergy Immunol. 2013 Feb;24(1):33-8. doi: 10.1111/pai.12032.

Reference Type: RESULT

PMID: 23331528 (View on PubMed)

Other Identifiers

P04292

Identifier Type: -

Identifier Source: org_study_id