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

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

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

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

Resource links provided by NLM:

Drug Information available for: Mometasone furoate

U.S. FDA Resources

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

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Locations

United States, California
Investigational Site 54
Fresno, California, United States, 93720
Investigational Site 56
Downey, California, United States, 90241
United States, Missouri
Investigational Site 7
St. Louis, Missouri, United States, 63141
United States, New York
Investigational Site 49
Buffalo, New York, United States, 14209
Investigational Site 6
Valhalla, New York, United States, 10595
United States, Oklahoma
Investigational Site 50
Oklahoma City, Oklahoma, United States, 73120
United States, Texas
Investigational Site 42
Dallas, Texas, United States, 75246
Investigational Site 42
Dallas, Texas, United States, 75246
Investigational Site 55
San Antonio, Texas, United States, 78229
United States, Virginia
Investigational Site 47
Richmond, Virginia, United States, 23229
Colombia
Investigational Site 9
Bogota, Colombia
Investigational Site 12
Bogota, Colombia
Investigational Site 11
Bogota, Colombia
Investigational Site 10
Medellin, Colombia, 04
El Salvador
Investigational Site 18
San Salvador, El Salvador
Guatemala
Investigational Site 15
Guatemala, Guatemala, 01015
Investigational Site 51
Guatemala, Guatemala
Investigational Site 13
Guatemala, Guatemala, 01011
Honduras
Investigational Site 16
San Pedro Sula, Honduras
Investigational Site 17
San Pedro Sula, Honduras
Panama
Investigational Site 19
Panama, Panama
Peru
Investigational Site 20
Pueblo Libre, Peru, 21
Investigational Site 21
Miraflores, Peru, 18
Investigational Site 22
Cercado de Lima, Peru, 1
Investigational Site 23
La Victoria, Peru, Lima 13
Puerto Rico
Investigational Site 24
Rio Piedras, Puerto Rico, 00935
Singapore
Investigational Site 26
Singapore, Singapore, 119074
South Africa
Investigational Site 28
Benoni, South Africa, 1500

Sponsors and Collaborators

Schering-Plough

Investigators

Study Director:

Ariel Teper, MD

Schering-Plough

More Information

No publications provided

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

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Pathological Conditions, Anatomical
Nasal Polyps
Otorhinolaryngologic Diseases
Therapeutic Uses

Mometasone furoate
Polyps
Anti-Allergic Agents
Pharmacologic Actions
Nose Diseases

ClinicalTrials.gov processed this record on November 27, 2009