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

Primary Purpose

Chronic Fatigue Syndrome

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Sildenafil (Viagra)

Placebo

About this trial

This is an interventional treatment trial for Chronic Fatigue Syndrome

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Charles Drew University of Medicine and Science

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

sidenafil

placebo

Arm Description

sidenafil

placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00598585

First Posted

August 31, 2005

Last Updated

May 25, 2017

Sponsor

Charles Drew University of Medicine and Science

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00598585

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

July 2002 (undefined)

Primary Completion Date

December 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charles Drew University of Medicine and Science

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Fatigue Syndrome

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

sidenafil

Arm Type

Experimental

Arm Description

sidenafil

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Drug

Intervention Name(s)

Sildenafil (Viagra)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo pills 3X/day for 6 weeks

Primary Outcome Measure Information:

Title

Change in Fatigue Impact Scale at 6 Weeks

Description

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

49 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ted C Friedman, M.D., Ph.D.

Organizational Affiliation

Charles Drew University of Medicine and Science

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charles Drew University of Medicine and Science

City

Los Angeles

State/Province

California

ZIP/Postal Code

90059

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.centerwatch.com

Description

Clinical Trial Research site

Learn more about this trial

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

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