Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Charles Drew University of Medicine and Science.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Charles Drew University of Medicine and Science
Collaborator:
Pfizer
Information provided by:
Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00598585
First received: August 31, 2005
Last updated: February 23, 2009
Last verified: February 2009
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Purpose
Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Fatigue Syndrome |
Drug: Sildenafil (Viagra) Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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. |
Resource links provided by NLM:
Further study details as provided by Charles Drew University of Medicine and Science:
Primary Outcome Measures:
- The principal aim of this study is to determine whether chronic fatigue syndrome (CFS) is due to inadequate blood flow to the brain and to test a medication, Viagra, which should help increase blood flow to the brain and improve the symptoms of CFS. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2002 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Double Blind study- one group will be on Sildenafil (Viagra) and the other group will be on placebo.
|
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.
|
| Placebo Comparator: 2 |
Drug: Placebo
Placebo
|
Detailed Description:
Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients with Chronic Fatigue Syndrome.
Eligibility| Ages Eligible for Study: | 18 Years to 49 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Patients meeting the CDC definition of CFS.
- All races, ethnicities, socio-economic status (SES), and gender
- Age greater than 18 (because of concerns about radioactivity, we and the Cedars-Sinai and Harbor-UCLA IRBs have decided not to enroll subjects below the age of 18).
- Age less than 50. Because of concern of sildenafil exacerbating coronary artery disease, we will only enroll patients younger than 50.
- Able to provide informed consent.
- Willingness to be off all medicines and supplements for 3 weeks prior to the study.
- Patients with psychiatric disorders (see below) will be included, if they could be off their medications, and if their psychiatric diagnosis clearly occurred after their fatigue symptoms began.
- Patients with concurrent fibromyalgia will be allowed to participate if the meet diagnostic criteria for CFS.
Exclusion Criteria:
- Disabilities that would prevent them from participating in the study.
- Current use of prescription medicines (starting at 3 weeks prior to the study) and supplements (starting at 1 weeks prior to the study) except acetaminophen or aspirin. This includes herbal supplements and vitamins.
- Existing medical illnesses, such as heart disease, hypertension, cancer, rheumatological diseases, endocrinopathies or hormone replacement therapy, seizure disorders, severe obesity (BMI > 32 kg/m2),
- Severe psychiatric disorders including bipolar disorder, schizophrenia, dementia and previous or current diagnosis of alcohol or substance abuse within the past year. Patients with depression of such severity as to warrant treatment with anti-depressants will be excluded.
- Current abuse of illicit drugs or heavy ethanol use.
- Pregnant women will be excluded because of radioactivity exposure from the SPECT scans.
- Abnormal EKG
- Abnormal CBC, blood chemistries, thyroid function tests, and HIV, ANA, RF and ESR tests.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598585
Contacts
| Contact: Erik Zuckerbraun, M.D. | 310.668.8754 | erikzuckerbraun@cdrewu.edu |
| Contact: Christian Gastelum, M.D. | 310.668.8754 | christiangastelum@cdrewu.edu |
Locations
| United States, California | |
| Charles Drew University of Medicine and Science | 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. | |
Sponsors and Collaborators
Charles Drew University of Medicine and Science
Pfizer
Investigators
| Principal Investigator: | Ted C Friedman, M.D., Ph.D. | Charles Drew University of Medicine and Science |
More Information
Additional Information:
No publications provided
| Responsible Party: | Theodore C. Friedman, M.D.,Ph.D. principal investigator, Charles Drew University of Medicine and Science |
| ClinicalTrials.gov Identifier: | NCT00598585 History of Changes |
| Other Study ID Numbers: | 02-04-378-07 |
| Study First Received: | August 31, 2005 |
| Last Updated: | February 23, 2009 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Fatigue Fatigue Syndrome, Chronic Signs and Symptoms Virus Diseases Muscular Diseases Musculoskeletal Diseases Encephalomyelitis Central Nervous System Diseases Nervous System Diseases Neuromuscular Diseases |
Sildenafil Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 17, 2013