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Sponsors and Collaborators: |
Charles Drew University of Medicine and Science Pfizer |
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Information provided by: | Charles Drew University of Medicine and Science |
ClinicalTrials.gov Identifier: | NCT00598585 |
Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)
Condition | Intervention | Phase |
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Chronic Fatigue Syndrome |
Drug: Sildenafil (Viagra) Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Phase 4 Study of the Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With Chronic Fatigue Syndrome. |
Estimated Enrollment: | 30 |
Study Start Date: | July 2002 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Double Blind study- one group will be on Sildenafil (Viagra) and the other group will be on placebo.
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Drug: Sildenafil (Viagra)
25 mg tid of either Sildenafil(Viagra) or Placebo for first week. 50 mg tid of either Sildenafil (Viagra)or Placebo for second week. 100 mg tid of either Sildenafil (Viagra)or Placebo for 3rd,4th, 5th and 6th week of study participation.
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2: Placebo Comparator |
Drug: Placebo
Placebo
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Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients with Chronic Fatigue Syndrome.
Ages Eligible for Study: | 18 Years to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erik Zuckerbraun, M.D. | 310.668.8754 | erikzuckerbraun@cdrewu.edu |
Contact: Christian Gastelum, M.D. | 310.668.8754 | christiangastelum@cdrewu.edu |
United States, California | |
Charles R. Drew University | Recruiting |
Los Angeles, California, United States, 90059 | |
Contact: Erik Zuckerbraun, M.D. 310-668-8754 erzucker@cdrewu.edu | |
Contact: Christian Gastelum, M.D. 310.668.8754 Christiangastelum@cdrewu.edu | |
Principal Investigator: Ted C Friedman, M.D., Ph.D. |
Principal Investigator: | Ted C Friedman, M.D., Ph.D. | Charles R. Drew University |
Responsible Party: | Charles Drew University ( Theodore C. Friedman, M.D.,Ph.D. principal investigator ) |
Study ID Numbers: | 02-04-378-06 |
Study First Received: | August 31, 2005 |
Last Updated: | January 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00598585 |
Health Authority: | United States: Institutional Review Board |
Virus Diseases Signs and Symptoms Muscular Diseases Fatigue Neuromuscular Diseases Musculoskeletal Diseases |
Myalgic encephalomyelitis Central Nervous System Diseases Sildenafil Encephalomyelitis Fatigue Syndrome, Chronic |
Vasodilator Agents Phosphodiesterase Inhibitors Pathologic Processes Disease Molecular Mechanisms of Pharmacological Action Therapeutic Uses |
Syndrome Nervous System Diseases Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions |