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This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days at minimum and eligibility for inclusion in this study will be assessed. Following the observation period, eligible subjects will be randomized to MF or MF placebo for a 2-week double-blind treatment. At each clinic visit (at the start of treatment and after 1 and 2 weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse events (AEs), will be evaluated. A 30-day follow-up visit will take place after the completion (or discontinuation) of the 2-week treatment period, to confirm presence or absence of serious adverse events (SAEs) and trial procedure-related AEs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone furoate nasal spray (MFNS) (50 μg spray device) | Experimental | The dose will be as follows:
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| MF placebo nasal spray | Placebo Comparator | Administration will be as follows:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone furoate | Drug | The study drug is MFNS (50 μg spray device) and the dose will be:
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score at 2 Weeks | 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, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. | Baseline and 2 weeks (or discontinuation) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Total Nasal Symptom Score at 1 Week | 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, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. | Baseline and 1 week |
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Inclusion Criteria:
Pediatric subjects with perennial allergic rhinitis who satisfy all of the following main criteria:
Exclusion Criteria:
Subjects for whom any of the main exclusion criteria below is applicable will not be registered in this study.
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Okamoto Y, Suzuki I . Multicenter, double-blind, randomized, placebo-controlled study of mometasone furoate nasal spray in Japanese pediatric subjects with perennial allergic rhinitis . Oto-rhino Laryngol Tokyo. 2013;106(11):1045-1057. |
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| ID | Title | Description |
|---|---|---|
| FG000 | MFNS | Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
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| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Drug | MF Placebo nasal spray and administration will be as follows:
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| Placebo |
Placebo MFNS. Administration was as follows:
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | MFNS | Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:
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| BG001 | Placebo | Placebo MFNS. Administration was as follows:
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| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 in the Total Nasal Symptom Score at 2 Weeks | 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, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 2 weeks (or discontinuation) |
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| Secondary | Change From Baseline in the Total Nasal Symptom Score at 1 Week | 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, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 1 week |
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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 nasal spray device. The dose was as follows:
| 0 | 220 | 24 | 220 | ||
| EG001 | Placebo | Placebo MFNS. Administration was as follows:
| 0 | 113 | 19 | 113 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Naspharyngitis | Infections and infestations | MedDRA 13.0 |
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| Epistaxis | Respiratory, thoracic and mediastinal 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, review copies of abstracts or manuscripts for publication that report any results of the trial. The Sponsor shall have the right to review and comment with respect to publications, abstracts, slides, and manuscripts and the right to review and comment on the data analysis and presentation.
| 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 |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Male |
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