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The purpose of this study is to determine the ability of Vascana (0.9% nitroglycerin topical cream) to treat and prevent the symptoms experienced by subject's with Raynaud's Phenomenon. The symptoms of this disease include pain, tingling, and numbness in the fingers of the affected hand or hands.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Sequence A | Experimental | Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream |
|
| Treatment Sequence B | Experimental | Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vehicle cream, Vascana® (0.9% nitroglycerin cream) |
|
| Treatment Sequence C | Experimental | Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream) |
|
| Treatment Sequence D | Experimental | Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vascana® (0.9% nitroglycerin cream), Vehicle cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascana (0.9% nitroglycerin cream) | Drug | Study drug administered topically |
|
| Measure | Description | Time Frame |
|---|---|---|
| Raynaud's Symptom Severity (Change From Baseline) | Change from baseline to visit 6 in peak Main Raynaud's Symptom (MRS) severity. Raynaud's symptoms will be assessed separately using a 0 to100-mm Visual Analog Scale (VAS) for pain, numbness, and tingling where 0 mm = no symptom and 100 mm = most severe symptom. | 6 weeks |
| Raynaud's Symptom Severity (Percentage of Responders) | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple investigational sites | Multiple Locations | Pennsylvania | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence A | Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream Vascana (0.9% nitroglycerin cream): Study drug administered topically Vehicle Cream (placebo): Vehicle administered topically |
| FG001 | Treatment Sequence B | Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vehicle cream, Vascana® (0.9% nitroglycerin cream) Vascana (0.9% nitroglycerin cream): Study drug administered topically Vehicle Cream (placebo): Vehicle administered topically |
| FG002 | Treatment Sequence C | Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream) Vascana (0.9% nitroglycerin cream): Study drug administered topically Vehicle Cream (placebo): Vehicle administered topically |
| FG003 | Treatment Sequence D | Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vascana® (0.9% nitroglycerin cream), Vehicle cream Vascana (0.9% nitroglycerin cream): Study drug administered topically Vehicle Cream (placebo): Vehicle administered topically |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence A | Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream Vascana (0.9% nitroglycerin cream): Study drug administered topically Vehicle Cream (placebo): Vehicle administered topically |
| BG001 | Treatment Sequence B |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Raynaud's Symptom Severity (Change From Baseline) | Change from baseline to visit 6 in peak Main Raynaud's Symptom (MRS) severity. Raynaud's symptoms will be assessed separately using a 0 to100-mm Visual Analog Scale (VAS) for pain, numbness, and tingling where 0 mm = no symptom and 100 mm = most severe symptom. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 6 weeks |
|
6 weeks
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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 | Vascana | Vascana (0.9% nitroglycerin cream): Study drug administered topically |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood Pressure Increased | Vascular disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Interest | Covis Pharma | 18773744177 | CTInterest@covispharma.com |
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| Vehicle Cream (placebo) | Drug | Vehicle administered topically |
|
Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vehicle cream, Vascana® (0.9% nitroglycerin cream) Vascana (0.9% nitroglycerin cream): Study drug administered topically Vehicle Cream (placebo): Vehicle administered topically |
| BG002 | Treatment Sequence C | Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vehicle cream, Vascana® (0.9% nitroglycerin cream) Vascana (0.9% nitroglycerin cream): Study drug administered topically Vehicle Cream (placebo): Vehicle administered topically |
| BG003 | Treatment Sequence D | Vehicle cream, Vascana® (0.9% nitroglycerin cream), Vascana® (0.9% nitroglycerin cream), Vehicle cream Vascana (0.9% nitroglycerin cream): Study drug administered topically Vehicle Cream (placebo): Vehicle administered topically |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Raynaud's Symptom Severity (Percentage of Responders) | Posted | Count of Participants | Participants | 6 weeks |
|
|
|
| 0 |
| 65 |
| 17 |
| 65 |
| 1 |
| 17 |
| EG001 | Vehicle Cream | Vehicle Cream (placebo): Vehicle administered topically | 0 | 65 | 16 | 65 | 3 | 16 |
| Nervous System Disorders | Nervous system disorders | Systematic Assessment |
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| General disorders and administration site conditions | General disorders | Systematic Assessment |
|
| Infections and infestations | Infections and infestations | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
|
| Respiratory, thoracic and mediastinal disorders | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Blood Pressure Increased | Vascular disorders | Systematic Assessment |
|
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