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

This study has been completed.
Sponsor:
Information provided by:
Schering-Plough
ClinicalTrials.gov Identifier:
NCT00378378
First received: September 18, 2006
Last updated: June 24, 2010
Last verified: June 2010
History of Changes
Results First Received: June 24, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Nasal Polyps
Interventions: Drug: Mometasone Furoate Nasal Spray (MFNS)
Drug: Placebo nasal spray

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
Pooled Placebo All placebo groups were combined

Participant Flow:   Overall Study
    MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years     MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years     Pooled Placebo  
STARTED     51     50     26  
COMPLETED     51     49     24  
NOT COMPLETED     0     1     2  
Withdrawal by Subject                 0                 1                 0  
Treatment Failure                 0                 0                 1  
Non-compliance with protocol                 0                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
Pooled Placebo All placebo groups were combined
Total Total of all reporting groups

Baseline Measures
    MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years     MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years     Pooled Placebo     Total  
Number of Participants  
[units: participants]
 		  51     50     26     127  
Age, Customized  
[units: participants]
 		       
6 to < 12 years     18     18     10     46  
12 to < 18 years     33     32     16     81  
Age  
[units: years]
Mean ± Standard Deviation 		  9.6  ± 1.4     14.4  ± 1.8     12.7  ± 3.2     12.7  ± 2.9  
Gender  
[units: participants]
 		       
Female     20     22     12     54  
Male     31     28     14     73  



  Outcome Measures
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1.  Primary:   Change From Baseline 24-hour Urinary Free Cortisol Level   [ Time Frame: Baseline to Endpoint ]
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2.  Secondary:   Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine   [ Time Frame: Baseline to Endpoint ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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