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Study of T3 for the Treatment of Fibromyalgia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sean Mackey, Stanford University
ClinicalTrials.gov Identifier:
NCT00903877
First received: May 15, 2009
Last updated: June 15, 2017
Last verified: June 2017
Results First Received: April 3, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Fibromyalgia
Intervention: Drug: T3

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Placebo Followed by T3 Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.

Participant Flow:   Overall Study
    Placebo Followed by T3
STARTED   51 
COMPLETED   8 
NOT COMPLETED   43 
Did not meet study criteria                33 
Withdrawal by Subject                3 
Adverse Event                2 
Lost to Follow-up                1 
Participation put on hold                4 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Each participant received placebo followed by 25 mcg of T3.

Reporting Groups
  Description
Placebo Followed by T3 Participants receive placebo for 4 weeks. Following placebo, participants begin T3 treatment at 25 mcg per day, for 4 weeks. Following this, participants begin T3 treatment at 50 mcg per day, for 4 more weeks.

Baseline Measures
   Placebo Followed by T3 
Overall Participants Analyzed 
[Units: Participants]
 51 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      51 100.0% 
>=65 years      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.35  (7.76) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      50  98.0% 
Male      1   2.0% 
Region of Enrollment 
[Units: Participants]
 
United States   51 


  Outcome Measures

1.  Primary:   Visual Analogue Scale of Pain Intensity   [ Time Frame: 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Sean Mackey, Chief, Division of Pain Medicine, Director, Stanford Systems Neuroscience and Pain Lab
Organization: Stanford University
phone: (650) 498-6477
e-mail: smackey@stanford.edu



Responsible Party: Sean Mackey, Stanford University
ClinicalTrials.gov Identifier: NCT00903877     History of Changes
Other Study ID Numbers: SU-04272009-2419
16295
Study First Received: May 15, 2009
Results First Received: April 3, 2017
Last Updated: June 15, 2017