Seasonal Allergic Rhinitis (SAR) Clinical Trial
— GSP 301-304Official title:
A Double-Blind, Randomized, Parallel-Group Seasonal Allergic Rhinitis (SAR) Study to Evaluate the Efficacy, Safety and Tolerability of GSP 301 Nasal Spray Compared With Placebo Nasal Spray and Individual Monotherapy Formulations (Olopatadine Hydrochloride Nasal Spray and Mometasone Furoate Nasal Spray) in Adult and Adolescent Subjects (12 Years of Age and Older)
| Verified date | April 2018 |
| Source | Glenmark Specialty S.A. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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)
| Status | Completed |
| Enrollment | 1176 |
| Est. completion date | January 2017 |
| Est. primary completion date | January 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: - Males and non-pregnant females who are 12 years of age and older. - Documented clinical history of SAR (for at least 2 years preceding the Screening Visit [Visit 1]) with exacerbations (clinical evidence of active symptoms) for the relevant seasonal allergen during the Fall or mountain cedar allergy seasons (e.g., ragweed or mountain cedar pollen) - A 12-hour rTNSS =8 out of a possible 12 and a congestion score =2 for the AM assessment at the Screening Visit (Visit 1). Exclusion Criteria: - Pregnant or lactating women. - History of anaphylaxis and/or other severe local reaction(s) to skin testing. - History of positive test for HIV, Hepatitis B or Hepatitis C infection. - Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip. - Subjects with an active pulmonary disorder or infection. - Subjects with posterior subcapsular cataracts or glaucoma - Plans to travel outside the known pollen area for the investigational site for 24 hours or longer during the last 7 days of the run-in period. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Investigational Site 415 | Austin | Texas |
| United States | Investigational Site 442 | Austin | Texas |
| United States | Investigational Site 428 | Aventura | Florida |
| United States | Investigational Site 405 | Bellevue | Nebraska |
| United States | Investigational Site 436 | Bethesda | Maryland |
| United States | Investigational Site 417 | Boerne | Texas |
| United States | Investigational Site 420 | Centennial | Colorado |
| United States | Investigational Site 419 | Cincinnati | Ohio |
| United States | United States 404 | Cincinnati | Ohio |
| United States | Investigational Site 444 | Colorado Springs | Colorado |
| United States | Investigational Site 443 | Columbia | Missouri |
| United States | Investigational Site 421 | Dallas | Texas |
| United States | Investigational Site 430 | Dallas | Texas |
| United States | Investigational Site 423 | Draper | Utah |
| United States | United States 407 | Edmond | Oklahoma |
| United States | Investigational Site 431 | El Paso | Texas |
| United States | Investigational Site 439 | Greenfield | Wisconsin |
| United States | Investigational Site 402 | High Point | North Carolina |
| United States | Investigational Site 433 | Kerrville | Texas |
| United States | Investigational Site 412 | Miami | Florida |
| United States | Investigational Site 426 | Minneapolis | Minnesota |
| United States | Investigational Site 406 | Mission Viejo | California |
| United States | Investigational Site 422 | New Braunfels | Texas |
| United States | Investigational Site 410 | Oklahoma City | Oklahoma |
| United States | Investigational Site 414 | Orange | California |
| United States | Investigational Site 411 | Pittsburgh | Pennsylvania |
| United States | Investigational Site 403 | Plymouth | Minnesota |
| United States | Investigational Site 427 | Raleigh | North Carolina |
| United States | Investigational Site 408 | Rochester | New York |
| United States | Investigational Site 418 | Rockville Centre | New York |
| United States | Investigational Site 441 | Rolla | Missouri |
| United States | Investigational Site 440 | Saint Louis | Missouri |
| 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 435 | San Diego | California |
| United States | Investigational Site 434 | Skillman | New Jersey |
| United States | Investigational Site 432 | South Dartmouth | Massachusetts |
| United States | Investigational Site 416 | Spartanburg | South Carolina |
| United States | Investigational Site 424 | Tulsa | Oklahoma |
| United States | Investigational Site 400 | Waco | Texas |
| United States | Investigational Site 409 | Waco | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Glenmark Specialty S.A. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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). | Baseline and day 14 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03463031 -
Efficacy and Safety of GSP 301 Nasal Spray in Children (Aged 6 to Under 12 Years) With Seasonal Allergic Rhinitis (SAR)
|
Phase 3 |