Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)
May 8, 2024 updated by: Organon and Co
Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
127
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 17 years (Child)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional 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
Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age
|
100 mcg nasal spray
Other Names:
|
|
Placebo Comparator: Placebo QD for subjects 6 to less than 12 years
|
One spray of placebo nasal spray in each nostril once daily for 4 months.
|
|
Experimental: MFNS 200 mcg QD for subjects 12 to less than 18 years
|
100 mcg nasal spray
Other Names:
|
|
Experimental: MFNS 200 mcg BID for subjects 12 to less than 18 years
|
100 mcg nasal spray
Other Names:
|
|
Placebo Comparator: Placebo QD for subjects 12 to less than 18 years
|
One spray of placebo nasal spray in each nostril once daily for 4 months.
|
|
Experimental: MFNS 100 mcg BID for subjects 6 to less than 12 years
|
100 mcg nasal spray
Other Names:
|
|
Placebo Comparator: Placebo BID for subjects 6 to less than 12 years
|
One spray of placebo nasal spray in each nostril once daily for 4 months.
|
|
Placebo Comparator: Placebo BID for subjects 12 to less than 18 years
|
One spray of placebo nasal spray in each nostril once daily for 4 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline 24-hour Urinary Free Cortisol Level
Time Frame: Baseline to Endpoint
|
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
Time Frame: Baseline to Endpoint
|
The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine).
|
Baseline to Endpoint
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2006
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
June 1, 2008
Study Registration Dates
First Submitted
September 18, 2006
First Submitted That Met QC Criteria
September 18, 2006
First Posted (Estimated)
September 20, 2006
Study Record Updates
Last Update Posted (Actual)
May 20, 2024
Last Update Submitted That Met QC Criteria
May 8, 2024
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P04292
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.