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

NCT00598585

Last updated date
Study Location
Charles Drew University of Medicine and Science
Los Angeles, California, 90059, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Chronic Fatigue Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-49 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Chronic Fatigue SyndromeUse of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS
NCT00598585
  1. Los Angeles, California
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS
Official Title  ICMJE 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.
Brief Summary Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)
Detailed Description Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients with Chronic Fatigue Syndrome.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Fatigue Syndrome
Intervention  ICMJE
  • 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.
  • Drug: Placebo
    Placebo pills 3X/day for 6 weeks
Study Arms  ICMJE
  • Experimental: sidenafil
    sidenafil
    Intervention: Drug: Sildenafil (Viagra)
  • Placebo Comparator: placebo
    placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 25, 2017)
12
Original Estimated Enrollment  ICMJE
 (submitted: January 21, 2008)
30
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date December 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 49 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00598585
Other Study ID Numbers  ICMJE 02-04-378-07
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Theodore Friedman, Charles Drew University of Medicine and Science
Study Sponsor  ICMJE Charles Drew University of Medicine and Science
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Ted C Friedman, M.D., Ph.D.Charles Drew University of Medicine and Science
PRS Account Charles Drew University of Medicine and Science
Verification Date April 2017

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