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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
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Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)
Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients with Chronic Fatigue Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sidenafil | Experimental | sidenafil |
|
| placebo | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sildenafil (Viagra) | Drug | 25 mg tid of either Sildenafil(Viagra) for first week. 50 mg tid of either Sildenafil (Viagra) for second week. 100 mg tid of either Sildenafil (Viagra) 3rd,4th, 5th and 6th week of study participation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fatigue Impact Scale at 6 Weeks | change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ted C Friedman, M.D., Ph.D. | Charles Drew University of Medicine and Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charles Drew University of Medicine and Science | Los Angeles | California | 90059 | United States |
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| Label | URL |
|---|---|
| Clinical Trial Research site | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil | 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation. |
| FG001 | Placebo | Placebo: Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sildenafil | Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation. |
| BG001 | Placebo |
| 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 | Change in Fatigue Impact Scale at 6 Weeks | change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated | Posted | Mean | Standard Deviation | units on a scale | 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 | Sildenafil | Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | Cardiac disorders | Systematic Assessment | patient became dizzy after taking lasix |
small number of subjects enrolled in trial
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Theodore C. Friedman MD PhD | Charles R. Drew University | 3106685197 | theodorefriedman@cdrewu.edu |
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| ID | Term |
|---|---|
| D015673 | Fatigue Syndrome, Chronic |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D004679 | Encephalomyelitis |
| D000090862 | Neuroinflammatory Diseases |
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| ID | Term |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| Placebo | Drug | Placebo pills 3X/day for 6 weeks |
|
Placebo: Placebo tid for 6 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
|
| 0 |
| 5 |
| 1 |
| 5 |
| EG001 | Placebo | Placebo: Placebo | 0 | 6 | 0 | 6 |
|
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| D009422 | Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |