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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Syndrome, Chronic
Fatigue
Syndrome
Central Nervous System Diseases
Disease
Encephalomyelitis
Muscular Diseases
Musculoskeletal Diseases
Nervous System Diseases
Neuromuscular Diseases
Pathologic Processes
Signs and Symptoms
Virus Diseases
Sildenafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 20, 2014