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)
Information source: Schering-Plough
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nasal Polyps
Intervention: mometasone furoate nasal spray (Drug); mometasone furoate nasal spray (Drug); Placebo nasal spray (Drug); Placebo nasal spray (Drug); mometasone furoate nasal spray (Drug); mometasone furoate nasal spray (Drug); Placebo nasal spray (Drug); Placebo nasal spray (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Schering-Plough Official(s) and/or principal investigator(s):
Ariel Teper, MD, Study Director, Affiliation: Schering-Plough
Summary
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.
Clinical Details
Official title: Study of Nasonex® (Mometasone Furoate Nasal Spray) for the Treatment of Nasal Polyps in Pediatric Subjects 6 to <18 Years of Age
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study
Primary outcome: 24-hour urinary free cortisol level
Secondary outcome: 24-hour urinary free cortisol level corrected for creatinine
Eligibility
Minimum age: 6 Years.
Maximum age: 17 Years.
Gender(s): Both.
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.
Locations and Contacts
Investigational Site 9, Bogota, Colombia
Investigational Site 10, Medellin 04, Colombia
Investigational Site 11, Bogota, Colombia
Investigational Site 12, Bogota, Colombia
Investigational Site 18, San Salvador, El Salvador
Investigational Site 15, Guatemala 01015, Guatemala
Investigational Site 51, Guatemala, Guatemala
Investigational Site 13, Guatemala 01011, Guatemala
Investigational Site 16, San Pedro Sula, Honduras
Investigational Site 17, San Pedro Sula, Honduras
Investigational Site 19, Panama, Panama
Investigational Site 20, Pueblo Libre 21, Peru
Investigational Site 21, Miraflores 18, Peru
Investigational Site 22, Cercado de Lima 1, Peru
Investigational Site 23, La Victoria Lima 13, Peru
Investigational Site 24, Rio Piedras 00935, Puerto Rico
Investigational Site 26, Singapore 119074, Singapore
Investigational Site 28, Benoni 1500, South Africa
Investigational Site 54, Fresno, California 93720, United States
Investigational Site 56, Downey, California 90241, United States
Investigational Site 7, St. Louis, Missouri 63141, United States
Investigational Site 49, Buffalo, New York 14209, United States
Investigational Site 6, Valhalla, New York 10595, United States
Investigational Site 50, Oklahoma City, Oklahoma 73120, United States
Investigational Site 42, Dallas, Texas 75246, United States
Investigational Site 42, Dallas, Texas 75246, United States
Investigational Site 55, San Antonio, Texas 78229, United States
Investigational Site 47, Richmond, Virginia 23229, United States
Additional Information
Starting date: July 2006
Ending date: June 2008
Last updated: June 16, 2008
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