Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 50 of 112 for:    Chronic Fatigue Syndrome

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00598585
Recruitment Status : Completed
First Posted : January 22, 2008
Results First Posted : June 27, 2017
Last Update Posted : June 27, 2017
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Theodore Friedman, Charles Drew University of Medicine and Science

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Chronic Fatigue Syndrome
Interventions Drug: Sildenafil (Viagra)
Drug: Placebo
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Sildenafil Placebo
Hide 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
Reason Not Completed
Lost to Follow-up             1             0
Arm/Group Title Sildenafil Placebo Total
Hide 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 Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
39  (6) 38  (9) 38  (5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
5
  83.3%
4
  66.7%
9
  75.0%
Male
1
  16.7%
2
  33.3%
3
  25.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Hispanic or Latino
1
  16.7%
2
  33.3%
3
  25.0%
Not Hispanic or Latino
5
  83.3%
4
  66.7%
9
  75.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
6
 100.0%
6
 100.0%
12
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change in Fatigue Impact Scale at 6 Weeks
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sildenafil Placebo
Hide 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
Overall Number of Participants Analyzed 5 6
Mean (Standard Deviation)
Unit of Measure: units on a scale
-32.6  (31.5) -1.5  (12.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Sildenafil, Placebo
Comments [Not Specified]
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 [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Sildenafil Placebo
Hide 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 (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Sildenafil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/5 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Sildenafil Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/5 (20.00%)      0/6 (0.00%)    
Cardiac disorders     
dizziness  [1]  1/5 (20.00%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
patient became dizzy after taking lasix
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
Layout table for Results Point of Contact information
Name/Title: Theodore C. Friedman MD PhD
Organization: Charles R. Drew University
Phone: 3106685197
EMail: theodorefriedman@cdrewu.edu
Layout table for additonal information
Responsible Party: Theodore Friedman, Charles Drew University of Medicine and Science
ClinicalTrials.gov Identifier: NCT00598585     History of Changes
Other Study ID Numbers: 02-04-378-07
First Submitted: August 31, 2005
First Posted: January 22, 2008
Results First Submitted: April 14, 2017
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017