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| ID | Type | Description | Link |
|---|---|---|---|
| IND Number: 123164 | Other Identifier | Center for Drug Evaluation and Research (CDER) | |
| Study Number (GSP 301-201) | Other Identifier | Glenmark Pharmaceuticals Ltd. |
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Study to evaluate the two different strengths and dose regimen of GSP 301 to be effective in treatment of seasonal allergic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSP 301 Placebo NS | Placebo Comparator |
| |
| GSP 301-1 NS (QD) | Experimental |
| |
| GSP 301-2 NS (BID) | Experimental |
| |
| Olopatadine HCl-1 NS (QD) | Active Comparator |
| |
| Olopatadine HCl-2 NS (BID) | Active Comparator |
| |
| Mometasone Furoate-1 NS (QD) | Active Comparator |
| |
| Mometasone Furoate-2 NS (BID) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSP 301-1 NS (QD) | Drug | GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in rTNSS From Baseline to End of Treatment | Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching. The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome. The severity scale for each symptom evaluation was defined as follows:
| 14 days |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sudeesh Tantry, Ph.D | Glenmark Pharmaceuticals Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Glenmark Investigational Site 10 | Austin | Texas | United States | |||
| Glenmark Investigational Site 5 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31734334 | Derived | Andrews CP, Mohar D, Salhi Y, Tantry SK. Efficacy and safety of twice-daily and once-daily olopatadine-mometasone combination nasal spray for seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 2020 Feb;124(2):171-178.e2. doi: 10.1016/j.anai.2019.11.007. Epub 2019 Nov 15. |
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Subjects were enrolled at 10 sites in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSP 301 Placebo NS | GSP 301 placebo NS administered as 2 sprays/nostril |
| FG001 | GSP 301-1 NS (QD) | GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| GSP 301-2 NS (BID) | Drug | GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril |
|
| GSP 301 Placebo NS | Drug | GSP 301 placebo NS administered as 2 sprays/nostril |
|
| Olopatadine HCl-1 NS (QD) | Drug | Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril |
|
| Olopatadine HCl-2 NS (BID) | Drug | Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril |
|
| Mometasone Furoate-1 NS (QD) | Drug | Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril |
|
| Mometasone Furoate-2 NS (BID) | Drug | Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril |
|
| Austin |
| Texas |
| United States |
| Glenmark Investigational Site 6 | Austin | Texas | United States |
| Glenmark Investigational Site 2 | Kerrville | Texas | United States |
| Glenmark Investigational Site 7 | New Braunfels | Texas | United States |
| Glenmark Investigational Site 3 | San Antonio | Texas | United States |
| Glenmark Investigational Site 4 | San Antonio | Texas | United States |
| Glenmark Investigational Site 8 | San Antonio | Texas | United States |
| Glenmark Investigational Site 9 | San Antonio | Texas | United States |
| Glenmark Investigational Site 1 | Waco | Texas | United States |
| FG002 | Mometasone Furoate-1 NS (QD) | Mometasone furoate-1 NS (50 μg) administered as 2 sprays/nostril |
| FG003 | Olopatadine HCl-1 NS (QD) | Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril |
| FG004 | GSP 301-2 NS (BID) | GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril |
| FG005 | Mometasone Furoate-2 NS (BID) | Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril |
| FG006 | Olopatadine HCl-2 NS (BID) | Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | GSP 301 Placebo NS | GSP 301 placebo NS administered as 2 sprays/nostril |
| BG001 | GSP 301-1 NS (QD) | GSP 301-1 NS administered as 2 sprays/nostril |
| BG002 | Mometasone Furoate-1 NS (QD) | Mometasone furoate-1 NS administered as 2 sprays/nostril |
| BG003 | Olopatadine HCl-1 NS (QD) | Olopatadine HCl-1 NS administered as 2 sprays/nostril |
| BG004 | GSP 301-2 NS (BID) | GSP 301-2 NS administered as 2 sprays/nostril |
| BG005 | Mometasone Furoate-2 NS (BID) | Mometasone furoate-2 NS administered as 2 sprays/nostril |
| BG006 | Olopatadine HCl-2 NS (BID) | Olopatadine HCl-2 NS administered as 2 sprays/nostril |
| BG007 | 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Change in rTNSS From Baseline to End of Treatment | Subjects were asked to assess rTNSS (reflective Total Nasal Symptom Score), ie, an evaluation of symptom severity over the past 12 hours prior to the recording of the score. The TNSS was defined as the sum of the subject-reported symptom severity scores for the following four nasal symptoms, recorded by each subject in the diary: rhinorrhea, sneezing, nasal congestion, nasal itching. The total rTNSS scores for all four symptoms (i.e, the lowest possible score (0) and the highest possible score (12).) Higher score means a worse outcome. The severity scale for each symptom evaluation was defined as follows:
| The full analysis set (FAS) included all randomized subjects who received at least one dose of randomized study medication 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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AEs and SAEs were collected from the time of signing the informed consent form until the follow-up contact
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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 | GSP 301 placebo NS administered as 2 sprays/nostril | 0 | 159 | 0 | 159 | ||
| EG001 | GSP 301-1 NS (QD) | GSP 301-1 NS (QD) administered as 2 sprays/nostril | 1 | 158 | 0 | 158 | ||
| EG002 | Mometasone Furoate-1 NS (QD) | Mometasone furoate-1 NS (QD) administered as 2 sprays/nostril | 0 | 160 | 0 | 160 | ||
| EG003 | Olopatadine HCl-1 NS (QD) | Olopatadine HCl-1 NS (QD) administered as 2 sprays/nostril | 0 | 158 | 0 | 158 | ||
| EG004 | GSP 301-2 NS (BID) | GSP 301-2 NS (BID) administered as 2 sprays/nostril. | 0 | 157 | 0 | 157 | ||
| EG005 | Mometasone Furoate-2 NS (BID) | Mometasone furoate-2 NS (BID) administered as 2 sprays/nostril | 0 | 159 | 0 | 159 | ||
| EG006 | Olopatadine HCl-2 NS (BID) | Olopatadine HCl-2 NS (BID) administered as 2 sprays/nostril | 0 | 160 | 0 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal ulcer and Gastritis | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment | There were two SAEs (gastrointestinal ulcer and gastritis) reported both in the same subject. |
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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 | |
|---|---|---|---|---|
| Cathy Tyrrell | Glenmark Pharmaceuticals Ltd | 91 2267720000 | 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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| ID | Term |
|---|---|
| C494814 | BID protein, human |
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| Male |
|
| Change from Baseline to Visit 4 |
|
| Mean Difference (Final Values) |
| -1.1703 |
| 2-Sided |
| 97.5 |
| -1.7315 |
| -0.6090 |
| Superiority |
| ANCOVA | 0.0020 | Mean Difference (Final Values) | -0.7718 | 2-Sided | 95 | -1.2616 | -0.2820 | Superiority |
| ANCOVA | 0.1524 | Mean Difference (Final Values) | -0.3563 | 2-Sided | 95 | -0.8445 | 0.1319 | Superiority |
| ANCOVA | 0.0488 | Mean Difference (Final Values) | -0.4918 | 2-Sided | 95 | -0.9810 | -0.0025 | Superiority |
| ANCOVA | 0.0043 | Mean Difference (Final Values) | -0.7133 | 2-Sided | 95 | -1.2031 | -0.2235 | Superiority |