Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS
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| ClinicalTrials.gov Identifier: NCT00598585 |
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Recruitment Status :
Completed
First Posted : January 22, 2008
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Fatigue Syndrome | Drug: Sildenafil (Viagra) Drug: Placebo | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 12 participants |
| 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. |
| Study Start Date : | July 2002 |
| Actual Primary Completion Date : | December 2010 |
| Actual Study Completion Date : | December 2010 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: sidenafil
sidenafil
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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. |
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Placebo Comparator: placebo
placebo
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Drug: Placebo
Placebo pills 3X/day for 6 weeks |
- 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
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| Ages Eligible for Study: | 18 Years to 49 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598585
| United States, California | |
| Charles Drew University of Medicine and Science | |
| Los Angeles, California, United States, 90059 | |
| Principal Investigator: | Ted C Friedman, M.D., Ph.D. | Charles Drew University of Medicine and Science |
| Responsible Party: | Theodore Friedman, Professor, Charles Drew University of Medicine and Science |
| ClinicalTrials.gov Identifier: | NCT00598585 |
| Other Study ID Numbers: |
02-04-378-07 |
| First Posted: | January 22, 2008 Key Record Dates |
| Results First Posted: | June 27, 2017 |
| Last Update Posted: | June 27, 2017 |
| Last Verified: | April 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Fatigue Syndrome, Chronic Syndrome Fatigue Disease Pathologic Processes Virus Diseases Infections 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 |

