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Sponsored by: |
Schering-Plough |
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Information provided by: | Schering-Plough |
ClinicalTrials.gov Identifier: | NCT00378378 |
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 |
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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 |
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.
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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.
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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.
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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.
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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.
|
Ages Eligible for Study: | 6 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Ariel Teper, MD | Schering-Plough |
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 |
Anti-Inflammatory Agents Pathological Conditions, Anatomical Nasal Polyps Otorhinolaryngologic Diseases |
Mometasone furoate Polyps Anti-Allergic Agents |
Anti-Inflammatory Agents Pathological Conditions, Anatomical Nasal Polyps Otorhinolaryngologic Diseases Therapeutic Uses |
Mometasone furoate Polyps Anti-Allergic Agents Pharmacologic Actions Nose Diseases |