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This study was conducted to see if mometasone nasal spray is efficaceous for the treatment of perennial allergic rhinitis. Patients will be randomized to active mometasone, placebo mometasone, active fluticasone, or placebo fluticasone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone Furoate Placebo (PLAMF) | Placebo Comparator | Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray |
|
| Fluticasone Propionate Placebo (PLAFP) | Placebo Comparator | Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray |
|
| Mometasone Furoate (MF) | Experimental | Mometasone furoate nasal spray 200 μg/day(QD) |
|
| Fluticasone Propionate (FP) | Active Comparator | Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo for MF | Drug | Placebo to mometasone furoate nasal spray, indistinguishable from mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks | The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points. | Baseline to 2 weeks of treatment |
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Inclusion Criteria:
Patients with perennial allergic rhinitis meeting all of the followings.
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | N. Sou et. al; Allergology & Immunology 16(3) page 394-413, (2009.02) -Japanese language journal |
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| ID | Title | Description |
|---|---|---|
| FG000 | Mometasone Furoate Placebo (PLAMF) | Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray |
| FG001 | Fluticasone Propionate Placebo (PLAFP) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo for FP | Drug | Placebo to fluticasone nasal spray, indistinguishable from fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks |
|
| Mometasone | Drug | Mometasone furoate nasal spray. Patients in this arm take 2 sprays per nostril once a day for 2 weeks |
|
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| Fluticasone | Drug | Fluticasone propionate nasal spray. Patients in this arm take 2 sprays per nostril twice a day for 2 weeks |
|
|
Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray
| FG002 | Mometasone Furoate (MF) | Mometasone furoate nasal spray 200 μg/day(QD) |
| FG003 | Fluticasone Propionate (FP) | Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID) |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mometasone Furoate Placebo (PLAMF) | Placebo to mometasone furoate nasal spray, made to be indistinguishable from mometasone furoate nasal spray |
| BG001 | Fluticasone Propionate Placebo (PLAFP) | Placebo to fluticasone propionate nasal spray, made to be indistinguishable from fluticasone propionate nasal spray |
| BG002 | Mometasone Furoate (MF) | Mometasone furoate nasal spray 200 μg/day(QD) |
| BG003 | Fluticasone Propionate (FP) | Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID) |
| 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, Customized | Number | participants |
| ||||||||||||||||
| 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 in 4 Nasal Symptom Score (Sneezing Attack, Rhinorrhea, Nasal Congestion, and Nasal Itching) After 2 Weeks | The nasal symptoms (sneezing attacks, rhinorrhea, nasal congestion and itching) were rated in 4 grades (+++: 3 points, ++: 2 points, +: 1 point, -: 0 point) based on the evaluation criteria for nasal symptoms. Total possible best score is 0 points, total possible worst score is 12 points. | Posted | Least Squares Mean | Standard Error | Units on a scale | Baseline to 2 weeks 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 Placebo and Fluticasone Propionate Placebo | Both placebo groups (arms) were combined to report adverse events | 0 | 66 | 4 | 66 | ||
| EG001 | Mometasone Furoate (MF) | Mometasone furoate nasal spray 200 μg/day(QD) | 0 | 143 | 11 | 143 | ||
| EG002 | Fluticasone Propionate (FP) | Fluticasone Propionate nasal spray 200 μg/day, twice per day (BID) | 1 | 142 | 4 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wisdom Teeth Removal | Surgical and medical procedures | MedDRA (9.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
|
The only restriction on the PI is that the PI needs to get approval from the sponsor for publication of the trial results prior to public release.
| 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 |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
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| 20-29 years old |
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| 30-39 years old |
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| 40-59 years old |
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| >=60 years old |
|
| Male |
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| Two Weeks |
|
| 95 |
| Superiority or Other (legacy) |