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 21, 2012
Last verified: June 2012

May 15, 2009
June 21, 2012
May 2009
June 2011   (final data collection date for primary outcome measure)
Visual analogue scale of pain intensity [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]
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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Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Fibromyalgia
  • Drug: T3
    Patients receive T3 in a dose of 25mcg and 50mcg
  • Drug: Placebo
    Patients receive a sugar pill
  • Experimental: T3
    Intervention: Drug: T3
  • Placebo Comparator: Placebo - sugar pill
    Intervention: Drug: Placebo
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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
Both
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00903877
SU-04272009-2419, 16295
Not Provided
Sean Mackey, Stanford University
Stanford University
Not Provided
Principal Investigator: Ian R Carroll Stanford University
Stanford University
June 2012

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