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| ID | Type | Description | Link |
|---|---|---|---|
| Study Number: GSP 301-304 | Other Identifier | Glenmark Specialty S.A. |
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Study to evaluate the efficacy, safety and tolerability of GSP 301 NS compared with placebo NS and individual monotherapy formulations for the treatment of Seasonal Allergic Rhinitis (subjects 12 years of age and older)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSP 301 NS | Experimental |
| |
| GOM-NS | Active Comparator |
| |
| GMM-2 NS | Active Comparator |
| |
| GSP 301 placebo NS | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSP 301 NS | Drug | 2 spray in each nostril twice daily for 14 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged 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). | Baseline and day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudeesh Tantry, PhD | Glenmark Pharmaceuticals Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site 406 | Mission Viejo | California | United States | |||
| Investigational Site 414 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30910440 | Derived | Gross GN, Berman G, Amar NJ, Caracta CF, Tantry SK. Efficacy and safety of olopatadine-mometasone combination nasal spray for the treatment of seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2019 Jun;122(6):630-638.e3. doi: 10.1016/j.anai.2019.03.017. Epub 2019 Mar 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | GSP 301 Placebo NS | 2 sprays/nostril twice daily for 14 days |
| FG001 | GSP 301 NS | 2 sprays/nostril twice daily for 14 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| GOM-NS |
| Drug |
2 spray in each nostril twice daily for 14 days |
|
| GMM-2 NS | Drug | 2 spray in each nostril twice daily for 14 days |
|
| GSP 301 placebo NS | Drug | 2 spray in each nostril twice daily for 14 days |
|
| Orange |
| California |
| United States |
| Investigational Site 435 | San Diego | California | United States |
| Investigational Site 420 | Centennial | Colorado | United States |
| Investigational Site 444 | Colorado Springs | Colorado | United States |
| Investigational Site 428 | Aventura | Florida | United States |
| Investigational Site 412 | Miami | Florida | United States |
| Investigational Site 436 | Bethesda | Maryland | United States |
| Investigational Site 432 | South Dartmouth | Massachusetts | United States |
| Investigational Site 426 | Minneapolis | Minnesota | United States |
| Investigational Site 403 | Plymouth | Minnesota | United States |
| Investigational Site 443 | Columbia | Missouri | United States |
| Investigational Site 441 | Rolla | Missouri | United States |
| Investigational Site 440 | St Louis | Missouri | United States |
| Investigational Site 405 | Bellevue | Nebraska | United States |
| Investigational Site 434 | Skillman | New Jersey | United States |
| Investigational Site 408 | Rochester | New York | United States |
| Investigational Site 418 | Rockville Centre | New York | United States |
| Investigational Site 402 | High Point | North Carolina | United States |
| Investigational Site 427 | Raleigh | North Carolina | United States |
| Investigational Site 419 | Cincinnati | Ohio | United States |
| United States 404 | Cincinnati | Ohio | United States |
| United States 407 | Edmond | Oklahoma | United States |
| Investigational Site 410 | Oklahoma City | Oklahoma | United States |
| Investigational Site 424 | Tulsa | Oklahoma | United States |
| Investigational Site 411 | Pittsburgh | Pennsylvania | United States |
| Investigational Site 416 | Spartanburg | South Carolina | United States |
| Investigational Site 415 | Austin | Texas | United States |
| Investigational Site 442 | Austin | Texas | United States |
| Investigational Site 417 | Boerne | Texas | United States |
| Investigational Site 421 | Dallas | Texas | United States |
| Investigational Site 430 | Dallas | Texas | United States |
| Investigational Site 431 | El Paso | Texas | United States |
| Investigational Site 433 | Kerrville | Texas | United States |
| Investigational Site 422 | New Braunfels | Texas | United States |
| Investigational Site 401 | San Antonio | Texas | United States |
| Investigational Site 413 | San Antonio | Texas | United States |
| Investigational Site 425 | San Antonio | Texas | United States |
| Investigational Site 437 | San Antonio | Texas | United States |
| Investigational Site 400 | Waco | Texas | United States |
| Investigational Site 409 | Waco | Texas | United States |
| Investigational Site 423 | Draper | Utah | United States |
| Investigational Site 439 | Greenfield | Wisconsin | United States |
| FG002 | Olopatadine HCl NS | 2 sprays/nostril twice daily for 14 days |
| FG003 | Mometasone Furoate NS | 2 sprays/nostril twice daily for 14 days |
| COMPLETED |
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| NOT COMPLETED |
|
GSP 301 placebo NS: Due to repeated participation of same subject in 2 seasons, only 1 participation (fall period) was included; Mometasone furoate NS: 1 subject received wrong kit and was excluded; GSP 301 NS and olopatadine HCl NS: Due to coinciding participation of same subject at 2 different sites, both participation's were excluded.
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| ID | Title | Description |
|---|---|---|
| BG000 | GSP 301 Placebo NS | 2 sprays/nostril twice daily for 14 days |
| BG001 | GSP 301 NS | 2 sprays/nostril twice daily for 14 days |
| BG002 | Olopatadine HCl NS | 2 sprays/nostril twice daily for 14 days |
| BG003 | Mometasone Furoate NS | 2 sprays/nostril twice daily for 14 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 |
| |||||||||||||||
| Sex: Female, Male | 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 From Baseline in Average AM and PM Subject-reported 12-hour Reflective Total Nasal Symptom Score (rTNSS) | The Reflective Total Nasal Symptom Score (rTNSS) was assessed by 12-hour reflective scoring of the severity of four nasal symptoms (rhinorrhea, sneezing, nasal congestion, nasal itching). Symptom scores ranged 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 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 | Baseline and day 14 |
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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., 7-10 days of screening and placebo run-in and 14 days of treatment.
Mometasone furoate NS: 1 subject received wrong kit and was excluded
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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 Placebo NS | 2 sprays/nostril twice daily for 14 days | 1 | 294 | 0 | 294 | ||
| EG001 | GSP 301 NS | 2 sprays/nostril twice daily for 14 days | 0 | 294 | 0 | 294 | ||
| EG002 | Olopatadine HCl NS | 2 sprays/nostril twice daily for 14 days | 2 | 294 | 0 | 294 | ||
| EG003 | Mometasone Furoate NS | 2 sprays/nostril twice daily for 14 days | 1 | 293 | 0 | 293 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Osteomyelitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Peritonsillar abscess | Infections and infestations | MedDRA (19.0) | Systematic Assessment |
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| Ischaemic stroke | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA (19.0) | Systematic Assessment |
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| Large intestinal obstruction | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Large intestine perforation | Gastrointestinal disorders | MedDRA (19.0) | Systematic Assessment |
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| Foot fracture | Injury, poisoning and procedural complications | MedDRA (19.0) | 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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| Change from baseline to end of treatment |
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| 0.028 |
| Superiority |
| ANCOVA | 0.019 | Superiority |
| ANCOVA | <0.001 | Superiority |
| ANCOVA | 0.002 | Superiority |