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Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Theodore Friedman, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier:
NCT00598585
First received: August 31, 2005
Last updated: May 25, 2017
Last verified: April 2017
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 Theodore Friedman, Charles Drew University of Medicine and Science:

Primary Outcome Measures:
  • Change in Fatigue Impact Scale at 6 Weeks [ Time Frame: 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


Enrollment: 12
Study Start Date: July 2002
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: sidenafil
sidenafil
Drug: Sildenafil (Viagra)
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.
Placebo Comparator: placebo
placebo
Drug: Placebo
Placebo pills 3X/day for 6 weeks

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   (Adult)
Sexes Eligible for Study:   All
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

Locations
United States, California
Charles Drew University of Medicine and Science
Los Angeles, California, United States, 90059
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:
Responsible Party: Theodore Friedman, Professor, 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
Results First Received: April 14, 2017
Last Updated: May 25, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Syndrome
Fatigue
Fatigue Syndrome, Chronic
Disease
Pathologic Processes
Signs and Symptoms
Virus Diseases
Muscular Diseases
Musculoskeletal Diseases
Encephalomyelitis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 18, 2017