Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS
NCT00598585
ABOUT THIS STUDY
FOR MORE INFORMATION
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- 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.
- 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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Descriptive Information | ||||
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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 |
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Study Arms ICMJE |
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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 | 12 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |
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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 |