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) - Full Text View

Purpose

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.

Condition	Intervention	Phase
Nasal Polyps	Drug: mometasone furoate nasal spray Drug: Placebo nasal spray	Phase III

ChemIDplus related topics:

Mometasone furoate Salicylsalicylic acid Sodium salicylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Official Title:	Study of Nasonex® (Mometasone Furoate Nasal Spray) for the Treatment of Nasal Polyps in Pediatric Subjects 6 to <18 Years of Age

Further study details as provided by Schering-Plough:

Primary Outcome Measures:

24-hour urinary free cortisol level [ Time Frame: 4 months of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

24-hour urinary free cortisol level corrected for creatinine [ Time Frame: 4 months of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	July 2006
Study Completion Date:	June 2008
Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
MFNS 100 mcg QD for subjects 6 to less than 12 years of age: Experimental	Drug: mometasone furoate nasal spray One spray of MFNS in each nostril (ie, 100 mcg) once daily for 4 months.
MFNS 100 mcg BID for subjects 6 to less than 12 years of age: Experimental	Drug: mometasone furoate nasal spray One spray of MFNS in each nostril (ie, 100 mcg) twice daily for 4 months.
Placebo QD for subjects 6 to less than 12 years of age: Placebo Comparator	Drug: Placebo nasal spray One spray of placebo nasal spray in each nostril once daily for 4 months.
Placebo BID for subjects 6 to less than 12 years of age: Placebo Comparator	Drug: Placebo nasal spray One spray of placebo nasal spray in each nostril twice daily for 4 months.
MFNS 200 mcg QD for subjects 12 to less than 18 years of age: Experimental	Drug: mometasone furoate nasal spray Two sprays of MFNS in each nostril (ie, 200 mcg) once daily for 4 months.
MFNS 200 mcg BID for subjects 12 to less than 18 years of age: Experimental	Drug: mometasone furoate nasal spray Two sprays of MFNS in each nostril (ie, 200 mcg) twice daily for 4 months.
Placebo QD for subjects 12 to less than 18 years of age: Placebo Comparator	Drug: Placebo nasal spray Two sprays of placebo nasal spray in each nostril once daily for 4 months.
Placebo BID for subjects 12 to less than 18 years of age: Placebo Comparator	Drug: Placebo nasal spray Two sprays of placebo nasal spray in each nostril twice daily for 4 months.

Eligibility

Ages Eligible for Study:	6 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378378

Show 28 Study Locations

Sponsors and Collaborators

Schering-Plough

Investigators


Study Director:	Ariel Teper, MD	Schering-Plough

More Information

Responsible Party:	Schering-Plough ( Heribert Staudinger, MD - Vice President, Global Clinical Research, Allergy/Respiratory/Immunology )
Study ID Numbers:	P04292
First Received:	September 18, 2006
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00378378
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Pathological Conditions, Anatomical

Nasal Polyps

Otorhinolaryngologic Diseases

Mometasone furoate

Salicylsalicylic acid

Sodium Salicylate

Polyps

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Therapeutic Uses

Anti-Allergic Agents

Pharmacologic Actions

Nose Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Schering-Plough
Information provided by:	Schering-Plough
ClinicalTrials.gov Identifier:	NCT00378378