Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSP 301 NS | Experimental |
| |
| GSP 301 Placebo NS pH 3.7 | Placebo Comparator |
| |
| GSP 301 Placebo NS pH 7.0 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSP 301 NS | Drug | FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sudeesh Tantry | Glenmark Pharmaceuticals S.A. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site 2 | Hot Springs | Arkansas | United States | |||
| Investigational Site 28 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31248471 | Derived | Segall N, Prenner B, Lumry W, Caracta CF, Tantry SK. Long-term safety and efficacy of olopatadine-mometasone combination nasal spray in patients with perennial allergic rhinitis. Allergy Asthma Proc. 2019 Sep 1;40(5):301-310. doi: 10.2500/aap.2019.40.4233. Epub 2019 Jun 27. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | GSP 301 NS | GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks |
| FG001 | GSP 301 Placebo NS pH 3.7 | GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 31, 2016 | Jul 20, 2018 |
Not provided
Not provided
Not provided
Not provided
Not provided
| GSP 301 Placebo NS pH 3.7 | Drug | 2 spray in each nostril twice daily for 52 weeks |
|
| GSP 301 Placebo NS pH 7.0 | Drug | 2 spray in each nostril twice daily for 52 weeks |
|
| Encinitas |
| California |
| United States |
| Investigational Site 27 | San Diego | California | United States |
| Investigational Site 29 | San Diego | California | United States |
| Investigational Site 32 | Denver | Colorado | United States |
| Investigational Site 26 | Aventura | Florida | United States |
| Investigational Site 9 | Miami | Florida | United States |
| Investigational Site 33 | Tallahassee | Florida | United States |
| Investigational Site 11 | Stockbridge | Georgia | United States |
| Investigational Site 4 | Louisville | Kentucky | United States |
| Investigational Site 5 | Bethesda | Maryland | United States |
| Investigational Site 15 | St Louis | Missouri | United States |
| Investigational Site 30 | Bellevue | Nebraska | United States |
| Investigational Site 19 | Skillman | New Jersey | United States |
| Investigational Site 18 | Corning | New York | United States |
| Investigational Site 7 | High Point | North Carolina | United States |
| Investigational Site 21 | Raleigh | North Carolina | United States |
| Investigational Site 16 | Sylvania | Ohio | United States |
| Investigational Site 22 | Pittsburgh | Pennsylvania | United States |
| Investigational Site 13 | Spartanburg | South Carolina | 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 31 | Dallas | Texas | United States |
| Investigational Site 34 | El Paso | Texas | United States |
| Investigational Site 6 | Kerrville | Texas | United States |
| Investigational Site 14 | New Braunfels | 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 1 | San Antonio | Texas | United States |
| Investigational Site 20 | San Antonio | Texas | United States |
| Investigational Site 25 | Waco | Texas | United States |
| Investigational Site 8 | Waco | Texas | United States |
| FG002 | GSP 301 Placebo NS pH 7.0 | GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Participants at the baseline measurement are less than that started because some subjects were not randomized or did not use the study drug on at least one occasion.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | GSP 301 NS | GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks |
| BG001 | GSP 301 Placebo NS pH 3.7 | GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks |
| BG002 | GSP 301 Placebo NS pH 7.0 | GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks |
| BG003 | 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 |
|
| 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 | 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. | Safety Analysis Set (SAS) will consist of all subjects who took at least 1 dose of study medication following randomization. This was the primary analysis set for safety analyses. | Posted | Number | participants | 52 weeks |
|
|
|
The AEs and SAEs were collected from the time of signing the informed consent form until the end of study until 52 weeks.
Total number of Participants at Risk is consistent with the number of participants reported at Baseline measurement. These participant numbers are not consistent with the numbers provided in the Participant Flow module because some of the subjects from the 'Total number at the start' were not randomized in the study or did not use the study drug on at least one occasion.
Not provided
| 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 | GSP 301 NS: 2 spray in each nostril twice daily for 52 weeks | 0 | 393 | 7 | 393 | 72 | 393 |
| EG001 | GSP 301 Placebo NS pH 3.7 | GSP 301 Placebo NS pH 3.7: 2 spray in each nostril twice daily for 52 weeks | 0 | 99 | 2 | 99 | 15 | 99 |
| EG002 | GSP 301 Placebo NS pH 7.0 | GSP 301 Placebo NS pH 7.0: 2 spray in each nostril twice daily for 52 weeks | 0 | 101 | 2 | 101 | 25 | 101 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholelithiasis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Ectopic pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA 18.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anaplastic astrocytoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Renal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
| |
| Triple negative breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Glenmark Pharmaceuticals Ltd. | 201-684 8000 | clinicaltrialsdisclosuredesk@glenmarkpharma.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 4, 2017 | Jul 20, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| 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 |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|