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
Sponsor:
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

August 31, 2005
February 23, 2009
July 2002
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00598585 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Fatigue Syndrome
  • 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.
  • Drug: Placebo
    Placebo
  • Experimental: 1
    Double Blind study- one group will be on Sildenafil (Viagra) and the other group will be on placebo.
    Intervention: Drug: Sildenafil (Viagra)
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 49 Years
Yes
Contact: Erik Zuckerbraun, M.D. 310.668.8754 erikzuckerbraun@cdrewu.edu
Contact: Christian Gastelum, M.D. 310.668.8754 christiangastelum@cdrewu.edu
United States
 
NCT00598585
02-04-378-07
Yes
Theodore C. Friedman, M.D.,Ph.D. principal investigator, Charles Drew University of Medicine and Science
Charles Drew University of Medicine and Science
Pfizer
Principal Investigator: Ted C Friedman, M.D., Ph.D. Charles Drew University of Medicine and Science
Charles Drew University of Medicine and Science
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP