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Study of T3 for the Treatment of Fibromyalgia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00903877
First Posted: May 19, 2009
Last Update Posted: July 14, 2017
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.
Information provided by (Responsible Party):
Sean Mackey, Stanford University
May 15, 2009
May 19, 2009
April 3, 2017
July 14, 2017
July 14, 2017
May 2009
June 2011   (Final data collection date for primary outcome measure)
Visual Analogue Scale of Pain Intensity [ Time Frame: 12 weeks ]
Patients rated their pain at baseline, placebo, T3 at 25 mcg, and T3 at 50 mcg. The scale ranged from 0 (no pain) to 10 (pain as bad as it can be).
Visual Analogue Scale of Pain Intensity
Complete list of historical versions of study NCT00903877 on ClinicalTrials.gov Archive Site
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Study of T3 for the Treatment of Fibromyalgia
T3 for Fibromyalgia: a Pilot Double-blind Non-randomized Clinical Trial
Determine if T3 - the active form of thyroid hormone - is beneficial in fibromyalgia. Determine the feasibility and promise of an appropriately powered future prospective randomized controlled study of using T3 (the active form of thyroid hormone) for the treatment of fibromyalgia. We specifically aim to assess the feasibility, cost, obstacles and promise of conducting a prospective controlled study in the future.
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Interventional
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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Fibromyalgia
Drug: T3
Patients receive T3 in a dose of 25mcg and 50mcg
Experimental: 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.
Intervention: Drug: T3
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
June 2011
June 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age 18-50
  2. Meet american college of rheumatology criteria for fibromyalgia
  3. at baseline report an average pain of 4 or more on a brief Pain Inventory.
  4. can climb 2 flights of stairs without shortness of breath.

Exclusion Criteria:

  1. new medication change in the last 2 months
  2. any cardiac disease at all
  3. known thyroid disease before or after thyroid screening bloodwork
  4. unstable medical or psychiatric disease.
  5. Known inflammatory or rheumatic disease other than fibromyalgia
  6. substance abuse in the last year
  7. suicidality or depression as indicated by a Beck Depression Inventory of 30 or above
  8. concomitant herbal medications
  9. multiple severe medication allergies
  10. the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study.
  11. diabetes
  12. smoking
  13. Known uncontrolled hypertension
  14. known uncontrolled hypercholesterolemia
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00903877
SU-04272009-2419
16295
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Sean Mackey, Stanford University
Stanford University
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Principal Investigator: Ian R Carroll Stanford University
Stanford University
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP