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This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Mometasone furoate nasal spray 200 mcg QD (once per day) |
|
| Arm 2 | Placebo Comparator | Matching placebo nasal spray |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone furoate nasal spray (MFNS) | Drug | MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days. | Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]) | 15 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days | Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. | 15 days of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Mometasone Furoate Nasal Spray | Mometasone furoate nasal spray 200 mcg QD (once per day) |
| FG001 | Placebo Nasal Spray | Matching placebo nasal spray |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mometasone Furoate Nasal Spray | Mometasone furoate nasal spray 200 mcg QD (once per day) |
| BG001 | Placebo Nasal Spray | Matching placebo nasal spray |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Change From Baseline in Average AM/PM PRIOR Nasal Congestion Score Over 15 Days. | Nasal congestion was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe. PRIOR (the subject's status over the previous 12 hours [reflective]) | Standard deviation is pooled. | Posted | Least Squares Mean | Standard Deviation | Units on a scale | 15 days of treatment |
|
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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 | Mometasone Furoate Nasal Spray | Mometasone furoate nasal spray 200 mcg QD (once per day) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck, Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D000068656 | Mometasone Furoate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Matching placebo nasal spray | Drug | Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days |
|
|
| Withdrawal by Subject |
|
| Protocol Violation |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
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|
|
| Secondary | The Change From Baseline in Average AM/PM PRIOR Total Nasal Symptom Score Over 15 Days | Total nasal symptom score (TNSS) is a composite of 4 symptoms, each is scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total can range from 0 to 12. | Standard deviation is pooled. | Posted | Least Squares Mean | Standard Deviation | Units on a scale | 15 days of treatment |
|
|
|
|
| 0 |
| 162 |
| 0 |
| 162 |
| EG001 | Placebo Nasal Spray | Matching placebo nasal spray | 0 | 162 | 0 | 162 |
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| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |