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

NCT00598585 | Completed Phase 4 Results DMC

• 1 other identifier: 02-04-378-07
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)

Conditions

Chronic Fatigue Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in Fatigue Impact Scale at 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

  6 weeks

Study Arms (2)

sidenafil

EXPERIMENTAL

sidenafil

Drug: Sildenafil (Viagra)

placebo

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Sildenafil (Viagra) DRUG

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.

sidenafil

Placebo DRUG

Placebo pills 3X/day for 6 weeks

placebo

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charles Drew University of Medicine and Science: lead
• Pfizer: collaborator

Study Sites (1)

Charles Drew University of Medicine and Science

Los Angeles, California, 90059, United States

Location

Related Links

• Clinical Trial Research site

MeSH Terms

Conditions

Fatigue Syndrome, Chronic

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Encephalomyelitis; Neuroinflammatory Diseases; Nervous System Diseases; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Limitations and Caveats

small number of subjects enrolled in trial

Results Point of Contact

• Title: Theodore C. Friedman MD PhD
• Organization: Charles R. Drew University

theodorefriedman@cdrewu.edu

3106685197

Study Officials

• Ted C Friedman, M.D., Ph.D.

  Charles Drew University of Medicine and Science

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: January 22, 2008
• Study Start: July 1, 2002
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 27, 2017
• Results First Posted: June 27, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)