Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With CFS
Study Details
Study Description
Brief Summary
Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients with Chronic Fatigue Syndrome.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Change in Fatigue Impact Scale at 6 Weeks [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
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 02-04-378-07
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Sildenafil | Placebo |
|---|---|---|
| Arm/Group Description | 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation. | Placebo: Placebo |
| Period Title: Overall Study | ||
| STARTED | 6 | 6 |
| COMPLETED | 5 | 6 |
| NOT COMPLETED | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Sildenafil | Placebo | Total |
|---|---|---|---|
| Arm/Group Description | Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation. | Placebo: Placebo tid for 6 weeks | Total of all reporting groups |
| Overall Participants | 6 | 6 | 12 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
39
(6)
|
38
(9)
|
38
(5)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
5
83.3%
|
4
66.7%
|
9
75%
|
| Male |
1
16.7%
|
2
33.3%
|
3
25%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
1
16.7%
|
2
33.3%
|
3
25%
|
| Not Hispanic or Latino |
5
83.3%
|
4
66.7%
|
9
75%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
| White |
6
100%
|
6
100%
|
12
100%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
| Title | Change in Fatigue Impact Scale at 6 Weeks |
|---|---|
| Description | 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 |
| Time Frame | 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Sildenafil | Placebo |
|---|---|---|
| Arm/Group Description | Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation. | Placebo: Placebo |
| Measure Participants | 5 | 6 |
| Mean (Standard Deviation) [units on a scale] |
-32.6
(31.5)
|
-1.5
(12.2)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Sildenafil, Placebo |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | unpaired test, the threshold for statistical significance was p= 0.05 | |
| Statistical Test of Hypothesis | p-Value | < 0.05 |
| Comments | ||
| Method | t-test, 2 sided | |
| Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Sildenafil | Placebo | ||
| Arm/Group Description | Sildenafil(Viagra): 25 mg tid of Sildenafil(Viagra) for first week. 50 mg tid of Sildenafil (Viagra) for second week. 100 mg tid of Sildenafil (Viagra) for 3rd,4th, 5th and 6th week of study participation. | Placebo: Placebo | ||
All Cause Mortality |
||||
| Sildenafil | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| Sildenafil | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/5 (0%) | 0/6 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Sildenafil | Placebo | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/5 (20%) | 0/6 (0%) | ||
| Cardiac disorders | ||||
| dizziness | 1/5 (20%) | 1 | 0/6 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Theodore C. Friedman MD PhD |
|---|---|
| Organization | Charles R. Drew University |
| Phone | 3106685197 |
| theodorefriedman@cdrewu.edu |
- 02-04-378-07