Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone Furoate Nasal Spray(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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MFNS 100 mcg QD for subjects 6 to less than 12 years | Experimental | Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age |
|
| Placebo QD for subjects 6 to less than 12 years | Placebo Comparator |
| |
| MFNS 200 mcg QD for subjects 12 to less than 18 years | Experimental |
| |
| MFNS 200 mcg BID for subjects 12 to less than 18 years | Experimental |
| |
| Placebo QD for subjects 12 to less than 18 years | Placebo Comparator |
| |
| MFNS 100 mcg BID for subjects 6 to less than 12 years | Experimental |
| |
| Placebo BID for subjects 6 to less than 12 years |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Drug | 100 mcg nasal spray |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline 24-hour Urinary Free Cortisol Level | The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to <18 years of age. Primary safety was to be assessed by determining the subject's 24-hour urinary free cortisol level. | Baseline to Endpoint |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine | The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine). | Baseline to Endpoint |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23331528 | Result | Chur V, Small CB, Stryszak P, Teper A. Safety of mometasone furoate nasal spray in the treatment of nasal polyps in children. Pediatr Allergy Immunol. 2013 Feb;24(1):33-8. doi: 10.1111/pai.12032. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years | Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID) |
| FG001 | MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years | Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD) |
| FG002 | Pooled Placebo | All placebo groups were combined |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years | Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID) |
| BG001 | MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline 24-hour Urinary Free Cortisol Level | The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to <18 years of age. Primary safety was to be assessed by determining the subject's 24-hour urinary free cortisol level. | Not all participants that were randomized had both a baseline and an endpoint urine sample. Only participants with both were included in the participants analyzed. | Posted | Least Squares Mean | Standard Deviation | mcg/hour | Baseline to Endpoint |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MFNS 100 or 200 mcg QD |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| EAR PAIN | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
The standard deviation is pooled for Primary and Secondary Outcome Measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice Presiden, Global Clinical Development | Merck, Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D009298 | Nasal Polyps |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D011127 | Polyps |
Not provided
Not provided
| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo Comparator |
|
| Placebo BID for subjects 12 to less than 18 years | Placebo Comparator |
|
|
| Placebo nasal spray | Drug | One spray of placebo nasal spray in each nostril once daily for 4 months. |
|
| Non-compliance with protocol |
|
Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD) |
| BG002 | Pooled Placebo | All placebo groups were combined |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years |
Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD) |
| OG002 | Pooled Placebo | All placebo groups were combined |
|
|
|
| Secondary | Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine | The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine). | Posted | Least Squares Mean | Standard Deviation | mcg/hour | Baseline to Endpoint |
|
|
|
|
| 0 |
| 50 |
| 24 |
| 50 |
| EG001 | MFNS 100 or 200 mcg BID | 0 | 51 | 23 | 51 |
| EG002 | Placebo | 0 | 26 | 13 | 26 |
| PYREXIA | General disorders | MedDRA 11.0 | Systematic Assessment |
|
| INFLUENZA | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| VIRAL UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| NASAL DISCOMFORT | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
| PHARYNGOLARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
Not provided
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
|
| ANOVA |
| 0.603 |
| 95 |
| Superiority or Other (legacy) |
| Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint. | ANOVA | 0.193 | 95 | Superiority or Other (legacy) |