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| Name | Class |
|---|---|
| Novum Pharmaceutical Research Services | INDUSTRY |
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To evaluate the therapeutic equivalence of the lest formulation of Mometasone Furoate Nasal Spray, 50 mcg to the marketed formulation NASONEX® (mometasone furoate monohydrate) Nasal Spray, 50 mcg/actuation in patients with seasonal allergic rhinitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mometasone Furoate Nasal Spray, 50 mcg | Experimental | Mometasone Furoate Nasal Spray, 50 mcg. 4 actuations per day for 14 days. |
|
| Nasonex Nasal Spray, 50 mcg | Active Comparator | Nasonex (mometasone furoate monohydrate) Nasal Spray, 50 mcg. 4 actuations per day for 14 days. |
|
| Placebo Nasal Spray | Placebo Comparator | Placebo of Mometasone Furoate Nasal Spray. 4 actuations per day for 14 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mometasone Furoate Nasal Spray, 50 mcg | Drug | a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline rTNSS | Change from baseline in average AM/PM reflective Total Nasal Symptom Score (rTNSS) over Days 1 to 14 | Days 1 - 14 |
| Total Nasal Symptom Score (TNSS) | The sum of patient-rated severity scores for four allergy symptoms : runny nose, nasal congestion, itchy nose, and sneezing based on a 4-point scale. | Days 1 - 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Baseline iTNSS | Change from baseline in average instantaneous Total Nasal Symptom Score (iTNSS) over Days 1 to 14. | Days 1 - 14 |
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Inclusion Criteria:
of the randomization visit.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keith Gallicano, PhD | Novum Pharmaceutical Reserach Services | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isis Clinical Research | Austin | Texas | 78731 | United States | ||
| Austin Clinical Research |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 30, 2021 | |
| Reset | May 21, 2021 |
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| Nasonex Nasal Spray, 50 mcg | Drug | a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate |
|
| Placebo Nasal Spray | Drug | a metered-dose, manual pump spray unit containing an aqueous suspension |
|
| Austin |
| Texas |
| 78750 |
| United States |
| Sirius Clinical Research | Austin | Texas | 78759 | United States |
| Kerrville Research Associates | Kerrville | Texas | 78028 | United States |
| Central Texas Health Research | New Braunfels | Texas | 78130 | United States |
| Allergy & Asthma Research Center | San Antonio | Texas | 78229 | United States |
| Biogenics Research Institute | San Antonio | Texas | 78229 | United States |
| Diagnostics Research Group | San Antonio | Texas | 78229 | United States |
| Sylvania Research | San Antonio | Texas | 78229 | United States |
| Allergy & Asthma Care of Waco | Waco | Texas | 76708 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 30, 2021 | May 21, 2021 |
| 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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| 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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