Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)
- Conditions
- -J339 Nasal polyp, unspecifiedNasal polyp, unspecifiedJ339
- Registration Number
- PER-066-06
- Lead Sponsor
- SCHERING PLOUGH RESEARCH INSTITUTE,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
1 A subject must be between 6 and <18 years of age, of any sex and race.
2. A subject must have a diagnosis of bilateral nasal polyps.
3 A subject must have a congestion / obstruction score> 1 on each of the last 2 days prior to the Start and the morning of the Start visit.
4 An asthmatic subject can be included.
5 Clinical laboratory tests of a subject should be within normal or clinically acceptable limits for the Investigator / sponsor.
6 The subject and the parents / guardians must be willing to give informed consent in writing, and the subject must be able to comply with the schedules of doses and visits.
7. A sexually active female sexually active person must have been using a contraceptive method before selection and must continue to use it while receiving the medication specified in the protocol.
1. A subject with antrochoanal polyps.
2. A subject with cystic fibrosis.
3 A subject with acute sinusitis, concurrent infection of the upper respiratory tract, or who had an upper respiratory tract infection within 2 weeks prior to the screening visit.
4. A subject with a history of acute angle-closure glaucoma, increased intraocular pressure, or post-hallucinatory subcapsular cataract or with any clinically significant condition or situation, other than the study condition that would make the evaluations or the optimal participation of the study difficult.
5. A subject that is immunocompromised.
6. A subject with rhinitis medicamentosa at present.
7. A subject with Churg-Strauss syndrome.
8. A subject with ciliary dyskinetic syndromes.
9 A subject who presents some abnormality, clinically significant, prior to treatment in laboratory tests, vital signs or ECG.
10. A subject with allergy / sensitivity to aspirin, corticosteroids, or study drug or its excipients.
11 A subject who has not observed the medication wash times summarized in the protocol before the screening visit.
12. A woman who is breastfeeding, who is pregnant, or who intends to become pregnant.
13. A subject who has used a investigational drug within 30 days of the selection.
14. A subject that is part of the personnel directly involved in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>Outcome name:A container will be given and the subject and the parents / guardians will be instructed to begin collecting the urine for 24 hours at 8 PM, 2 days before the scheduled visit for the collection of the sample.<br>Measure:24-hour free cortisol level in urine (corrected for creatinine).<br>Timepoints:Day 1 and month 4.<br>
- Secondary Outcome Measures
Name Time Method