Perennial Allergic Rhinitis Clinical Trial
— GSP 301-303Official title:
A Double-Blind, Randomized, Parallel-Group Study to Evaluate Long-Term Safety, Tolerability, and Efficacy of a Fixed Dose Combination GSP 301 Nasal Spray Compared With Two Placebo Nasal Spray Formulations in Subjects (Aged 12 Years and Older) With Perennial Allergic Rhinitis (PAR)
| Verified date | February 2020 |
| Source | Glenmark Specialty S.A. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To evaluate the long term safety and efficacy of GSP 301 NS compared to 2 placebo NS formulations for the treatment of perennial allergic rhinitis (subjects 12 years of age and older)
| Status | Completed |
| Enrollment | 601 |
| Est. completion date | July 2017 |
| Est. primary completion date | July 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 12 Years and older |
| Eligibility |
Inclusion Criteria: 1. Aged =12 years and older inclusive of either sex. 2. Documented clinical history of PAR (for at least 2 years preceding the Screening Visit [Visit 1]) and exhibiting a documented positive skin prick test (wheal diameter at least 3 mm greater than negative diluent control wheal) to at least 1 allergen known to induce PAR. Documentation of a positive result within 12 months prior to the Screening Visit (Visit 1) is acceptable. Exclusion Criteria: 1. Pregnant or lactating women. 2. History of anaphylaxis and/or other severe local reaction(s) to skin testing. 3. History of positive test for HIV, Hepatitis B or Hepatitis C infection. 4. Documented evidence of acute or significant chronic sinusitis or chronic purulent postnasal drip. 5. Subjects with an active pulmonary disorder or infection. 6. Subjects with posterior subcapsular cataracts or glaucoma |
| Country | Name | City | State |
|---|---|---|---|
| United States | Investigational Site 23 | Austin | Texas |
| United States | Investigational Site 24 | Austin | Texas |
| United States | Investigational Site 3 | Austin | Texas |
| United States | Investigational Site 26 | Aventura | Florida |
| United States | Investigational Site 30 | Bellevue | Nebraska |
| United States | Investigational Site 5 | Bethesda | Maryland |
| United States | Investigational Site 18 | Corning | New York |
| United States | Investigational Site 31 | Dallas | Texas |
| United States | Investigational Site 32 | Denver | Colorado |
| United States | Investigational Site 34 | El Paso | Texas |
| United States | Investigational Site 28 | Encinitas | California |
| United States | Investigational Site 7 | High Point | North Carolina |
| United States | Investigational Site 2 | Hot Springs | Arkansas |
| United States | Investigational Site 6 | Kerrville | Texas |
| United States | Investigational Site 4 | Louisville | Kentucky |
| United States | Investigational Site 9 | Miami | Florida |
| United States | Investigational Site 14 | New Braunfels | Texas |
| United States | Investigational Site 22 | Pittsburgh | Pennsylvania |
| United States | Investigational Site 21 | Raleigh | North Carolina |
| United States | Investigational Site 15 | Saint Louis | Missouri |
| United States | Investigational Site 1 | San Antonio | Texas |
| United States | Investigational Site 10 | San Antonio | Texas |
| United States | Investigational Site 12 | San Antonio | Texas |
| United States | Investigational Site 17 | San Antonio | Texas |
| United States | Investigational Site 20 | San Antonio | Texas |
| United States | Investigational Site 27 | San Diego | California |
| United States | Investigational Site 29 | San Diego | California |
| United States | Investigational Site 19 | Skillman | New Jersey |
| United States | Investigational Site 13 | Spartanburg | South Carolina |
| United States | Investigational Site 11 | Stockbridge | Georgia |
| United States | Investigational Site 16 | Sylvania | Ohio |
| United States | Investigational Site 33 | Tallahassee | Florida |
| United States | Investigational Site 25 | Waco | Texas |
| United States | Investigational Site 8 | Waco | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Glenmark Specialty S.A. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs). | All TEAEs and serious adverse events (SAEs) occurring in the study, in terms of nature, onset, duration, severity, relationship, and outcome were reported. | 52 weeks |
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|---|---|---|---|
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