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Study to evaluate the efficacy and safety of GSP 301 NS compared to placebo NS and to individual monotherapies (comparators) as well as the efficacy of these monotherapies (comparators) versus placebo NS over 14 days of study treatment
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSP 301 NS | Experimental |
| |
| Olopatadine HCl NS | Active Comparator |
| |
| Mometasone furoate NS | Active Comparator |
| |
| GSP 301 Placebo NS | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSP 301 NS | Drug | FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. | Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate). | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudeesh Tantry, PhD | Glenmark Pharmaceuticals S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site 20 | Mission Viejo | California | United States | |||
| Investigational Site 31 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31053180 | Derived | Hampel FC, Pedinoff AJ, Jacobs RL, Caracta CF, Tantry SK. Olopatadine-mometasone combination nasal spray: Evaluation of efficacy and safety in patients with seasonal allergic rhinitis. Allergy Asthma Proc. 2019 Jul 3;40(4):261-272. doi: 10.2500/aap.2019.40.4223. Epub 2019 May 3. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GSP 301 NS | 2 sprays in each nostril twice daily for 14 days |
| FG001 | Olopatadine HCl NS | 2 sprays in each nostril twice daily for 14 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Olopatadine HCl NS | Drug | 2 sprays in each nostril twice daily for 14 days |
|
| Mometasone furoate NS | Drug | 2 sprays in each nostril twice daily for 14 days |
|
| GSP 301 Placebo NS | Drug | 2 sprays in each nostril twice daily for 14 days |
|
| San Diego |
| California |
| United States |
| Investigational Site 29 | San Jose | California | United States |
| Investigational Site 25 | Centennial | Colorado | United States |
| Investigational Site 22 | Colorado Springs | Colorado | United States |
| Investigational Site 10 | Jupiter | Florida | United States |
| Investigational Site 30 | Miami | Florida | United States |
| Investigational Site 37 | Marietta | Georgia | United States |
| Investigational Site 15 | Stockbridge | Georgia | United States |
| Investigational Site 23 | Stockbridge | Georgia | United States |
| Investigational Site 11 | Louisville | Kentucky | United States |
| Investigational Site 14 | Baltimore | Maryland | United States |
| Investigational Site 33 | Wheaton | Maryland | United States |
| Investigational Site 26 | Ypsilanti | Michigan | United States |
| Investigational Site 19 | Minneapolis | Minnesota | United States |
| Investigational Site 21 | St Louis | Missouri | United States |
| Investigational Site 16 | Bellevue | Nebraska | United States |
| Investigational Site 12 | Skillman | New Jersey | United States |
| Investigational Site 36 | Rochester | New York | United States |
| Investigational Site 18 | Raleigh | North Carolina | United States |
| Investigational Site 27 | Cincinnati | Ohio | United States |
| Investigational Site 34 | Middleburg Heights | Ohio | United States |
| Investigational Site 32 | Medford | Oregon | United States |
| Investigational Site 35 | Portland | Oregon | United States |
| Investigational Site 13 | Orangeburg | South Carolina | United States |
| Investigational Site 17 | Spartanburg | South Carolina | United States |
| Investigational Site 3 | Austin | Texas | United States |
| Investigational Site 5 | Austin | Texas | United States |
| Investigational Site 8 | Austin | Texas | United States |
| Investigational Site 1 | Kerrville | Texas | United States |
| Investigational Site 7 | New Braunfels | Texas | United States |
| Investigational Site 2 | San Antonio | Texas | United States |
| Investigational Site 4 | San Antonio | Texas | United States |
| Investigational Site 6 | San Antonio | Texas | United States |
| Investigational Site 9 | San Antonio | Texas | United States |
| Investigational Site 28 | Waco | Texas | United States |
| Investigational Site 24 | Draper | Utah | United States |
| FG002 | Mometasone Furoate NS | 2 sprays in each nostril twice daily for 14 days |
| FG003 | GSP 301 Placebo NS | 2 sprays in each nostril twice daily for 14 days |
| COMPLETED |
|
| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | GSP 301 NS | 2 sprays in each nostril twice daily for 14 days |
| BG001 | Olopatadine HCl NS | 2 sprays in each nostril twice daily for 14 days |
| BG002 | Mometasone Furoate NS | 2 sprays in each nostril twice daily for 14 days |
| BG003 | GSP 301 Placebo NS | 2 sprays in each nostril twice daily for 14 days |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants | No |
| |||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants | No |
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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 Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptoms Score (rTNSS) From Baseline to End of Treatment. | Reflective Total Nasal Symptom Score (rTNSS) was calculated as the sum of 12-hour reflective scoring of the severity of four nasal symptoms (nasal congestion, rhinorrhea, nasal itching, sneezing). Subjects responded on a 4-point severity scale with scores ranging from 0 (no signs/symptoms evident) to 3 (severe signs/symptoms that is hard to tolerate). The rTNSS was calculated as the sum of the subject-reported severity scores for nasal symptoms, and value ranged from 0 (no signs/symptoms evident) to 12 (severe signs/symptoms that is hard to tolerate). | The Full Analysis Set (FAS) was defined as all subjects who were randomized and received at least one dose of investigational product and had at least one post-baseline primary efficacy assessment. This was the primary analysis set for efficacy analyses. | Posted | Mean | Standard Deviation | units on a scale | 14 days |
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The AEs and SAEs were collected from the time of signing the informed consent form until the end of study i.e., screening visit followed by 7-10 days of placebo run-in period and 14 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 | GSP 301 NS | 2 sprays in each nostril twice daily for 14 days | 0 | 302 | 1 | 302 | 0 | 302 |
| EG001 | Olopatadine HCl NS | 2 sprays in each nostril twice daily for 14 days | 0 | 297 | 0 | 297 | 0 | 297 |
| EG002 | Mometasone Furoate NS | 2 sprays in each nostril twice daily for 14 days | 0 | 294 | 0 | 294 | 0 | 294 |
| EG003 | GSP 301 Placebo NS | 2 sprays in each nostril twice daily for 14 days | 0 | 287 | 0 | 287 | 0 | 287 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
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Per the agreement, Sponsor reserves the right for publishing trial results and the Investigator cannot publish without written consent from the CRO/Sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Glenmark Pharmaceuticals Ltd. | (201) 684-8000 | clinicaltrialsdisclosuredesk@glenmarkpharma.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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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Change from baseline to end of treatment |
|
| Mixed Models Analysis |
| 0.0029 |
| Superiority |
| GSP 301 NS vs Mometasone furoate NS comparison for rTNSS was tested at 0.05 significance level. | Mixed Models Analysis | 0.0587 | Superiority |
| Olopatadine HCl NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level. | Mixed Models Analysis | 0.0755 | Superiority |
| Mometasone furoate NS vs GSP 301 Placebo NS comparison for rTNSS was tested at 0.05 significance level. | Mixed Models Analysis | 0.0043 | Superiority |