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Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between the Ages of 6 and Less Than 18 Years Old (Study P04292AM1)(COMPLETED)
This study has been completed.
Study NCT00378378   Information provided by Schering-Plough
First Received: September 18, 2006   Last Updated: July 24, 2008   History of Changes

September 18, 2006
July 24, 2008
July 2006
June 2008   (final data collection date for primary outcome measure)
24-hour urinary free cortisol level [ Time Frame: 4 months of treatment ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00378378 on ClinicalTrials.gov Archive Site
24-hour urinary free cortisol level corrected for creatinine [ Time Frame: 4 months of treatment ] [ Designated as safety issue: Yes ]
Same as current
 
Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between the Ages of 6 and Less Than 18 Years Old (Study P04292AM1)(COMPLETED)
Study of Nasonex® (Mometasone Furoate Nasal Spray) for the Treatment of Nasal Polyps in Pediatric Subjects 6 to <18 Years of Age

The purpose of this study is to evaluate the safety and efficacy of Nasonex® (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.

 
Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Nasal Polyps
  • Drug: mometasone furoate nasal spray
  • Drug: Placebo nasal spray
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
120
June 2008
June 2008   (final data collection date for primary outcome measure)

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.
Both
6 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Colombia,   El Salvador,   Guatemala,   Honduras,   Panama,   Peru,   Puerto Rico,   Singapore,   South Africa
 
NCT00378378
Heribert Staudinger, MD - Vice President, Global Clinical Research, Allergy/Respiratory/Immunology, Schering-Plough
P04292
Schering-Plough
 
Study Director: Ariel Teper, MD Schering-Plough
Schering-Plough
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP