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| ID | Type | Description | Link |
|---|---|---|---|
| JPC-04-342-41 |
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This is a multicenter, open-label, randomized, parallel group comparison study to verify the clinical equivalency of the old formulation (50 mcg as mometasone furoate [MF] in 50 μL of solution per spray) to the new formulation (50 mcg as MF in 100 μL of solution per spray) in patients with perennial allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| New Formulation Group | Experimental |
| |
| Old Formulation Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mometasone furoate | Drug | The dose will be 50 mcg as MF in one spray (100 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in 4 nasal symptom score (sneezing attack, rhinorrhea, nasal congestion, and nasal itching) from baseline at Week 2. | After 2 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in each nasal symptom (sneezing attack, rhinorrhea, nasal congestion, and nasal itching). | After 2 weeks of treatment | |
| Overall improvement | 2 weeks | |
| Adverse events |
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Inclusion Criteria:
Patients of mongoloid race residing in Japan who satisfy all of the following criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | T. Ishikawa et. al; Practica otologica. Suppl.123 Page1-18 (2008.12) -Japanese language journal |
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| 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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|
| mometasone furoate | Drug | The dose will be 50 mcg as MF in one spray (50 µL) per nostril two times a day (morning and night) for 2 weeks. The daily dose of MF will be 200 mcg. |
|
|
| From initial day of treatment until treatment is stopped. |
| Laboratory tests | At 7 or more days before treatment start, and after 2 weeks of treatment |
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |