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Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MFNS 50 μg device | Experimental | MFNS 50 μg spray device. The dose will be as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mometasone furoate | Drug | MFNS 50 μg spray device
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events and Adverse Drug Reactions | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score | Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms. | Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation) |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | MFNS | Mometasone furoate nasal spray (MFNS) 50 mcg device. Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks. Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | MFNS | Mometasone furoate nasal spray (MFNS) 50 mcg device. Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks. Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks. |
| 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 | Number of Participants With Adverse Events and Adverse Drug Reactions | All treated participants | Posted | Number | participants | Baseline to Week 24 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MFNS | Mometasone furoate nasal spray (MFNS) 50 mcg device. Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks. Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 13.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA 13.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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|
| Participant moved (relocated) |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | Participants |
|
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| Secondary | Change From Baseline in the Total Nasal Symptom Score | Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms. | All treated participants | Posted | Mean | Standard Error | units on a scale | Baseline and Weeks 2, 4, 8, 12, and 24 (or discontinuation) |
|
|
|
| 1 |
| 80 |
| 72 |
| 80 |
| Pyrexia | General disorders | MedDRA 13.0 |
|
| Acute sinusitis | Infections and infestations | MedDRA 13.0 |
|
| Acute tonsillitis | Infections and infestations | MedDRA 13.0 |
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| Bronchitis | Infections and infestations | MedDRA 13.0 |
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| Nasopharyngitis | Infections and infestations | MedDRA 13.0 |
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| Pharyngitis | Infections and infestations | MedDRA 13.0 |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 |
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| Blood cortisol decreased | Investigations | MedDRA 13.0 |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 |
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| Heat rash | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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The investigator agrees to provide to the Sponsor 45 days prior to submission for publication or presentation, reveiw copies of abstracts or manuscripts for publication that report any results of the trial. The Sponsor shall have the right to reveiw and comment with respect to publications, abstracts, slides, and manuscripts and the right to reveiw and comment on the data analysis and presentation.
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| Change at Week 12 |
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| Change at Week 24 |
|