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The purpose of this study is to evaluate how well mometasone furoate nasal spray (MFNS) works to relieve SAR symptoms compared to Placebo when symptoms are induced in a chamber setting. Evaluation will be based on subjects self-assessed nose symptoms. Other areas the study will evaluate are: 1) changes in eye symptoms (ocular symptom severity score) after dosing 2) how long MFNS works in relieving the nose (nasal) and eye (ocular) symptoms after 7 daily doses, 3) measurements of nose (nasal) blockage (obstruction), and 4) measurements of the subject's opinion of the study drugs by asking different questions. This study is could last up to 53 days for some subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone Furoate Nasal Spray (MFNS) | Experimental | MFNS 200 mcg total dose (2 sprays each nostril) |
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| Placebo | Placebo Comparator | Placebo (2 sprays each nostril) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray | Drug | Mometasone Furoate Nasal Spray: 2 sprays (50 mcg) each nostril (total 200 mcg) |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1 | Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea & itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, & disturbing some of the time; 3=Severe: sign/symptom very noticeable & very bothersome most of the time. | Baseline and 6 hours following initial dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21067660 | Result | Salapatek AM, Patel P, Gopalan G, Varghese ST. Mometasone furoate nasal spray provides early, continuing relief of nasal congestion and improves nasal patency in allergic patients. Am J Rhinol Allergy. 2010 Nov-Dec;24(6):433-8. doi: 10.2500/ajra.2010.24.3548. Epub 2010 Nov 10. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mometasone Furoate Nasal Spray Day 1 | Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose |
| FG001 | Placebo Day 1 | Placebo: 2 sprays each nostril for 1 dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Placebo | Other | Placebo: 2 sprays in each nostril |
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| FG002 | Mometasone Furoate Nasal Spray Day 8 | Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days |
| FG003 | Placebo Day 8 | Placebo: 2 sprays each nostril for 7 days |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Mometasone Furoate Nasal Spray Day 1 | Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose |
| BG001 | Placebo Day 1 | Placebo: 2 sprays each nostril for 1 dose |
| BG002 | Mometasone Furoate Nasal Spray Day 8 | Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days |
| BG003 | Placebo Day 8 | Placebo: 2 sprays each nostril for 7 days |
| BG004 | 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, Continuous | Mean | Standard Deviation | years |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Changes in the Total Nasal Symptom Severity Score (TNSS) at 6 Hours After Dosage Administration on Day 1 | Value at 6 hours after dosage administration (Day 1) minus value at Baseline. Minimum threshold TNSS response defined as TNSS score ≥6 out of a possible 12 for combined nasal symptoms of congestion, sneezing, rhinorrhea & itching with a score ≥2 for nasal congestion. Rating of the severity of the individual signs/symptoms according to the following scale: 0=None, sign/symptom wasn't present; 1=Mild, sign/symptom was present, but not disturbing; 2=Moderate, sign/symptom definitely present, & disturbing some of the time; 3=Severe: sign/symptom very noticeable & very bothersome most of the time. | Intent to treat population | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline and 6 hours following initial dosing |
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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 Day 1 | Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose | 0 | 77 | 1 | 77 | ||
| EG001 | Placebo Day 1 | Placebo: 2 sprays each nostril for 1 dose | 0 | 78 | 1 | 78 | ||
| EG002 | Mometasone Furoate Nasal Spray Day 8 | Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days | 0 | 78 | 6 | 78 | ||
| EG003 | Placebo Day 8 | Placebo: 2 sprays each nostril for 7 days | 0 | 77 | 4 | 77 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (10.0) | Systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 45 days from the time submitted to the sponsor for review. If the parties disagree on the communication, the investigator and sponsor's represnetatives will meet for the purpose of making a good faith effort to discuss and resolve any such issues or disagreement.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| 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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| Male |
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