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Study of T3 for the Treatment of Fibromyalgia

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Fibromyalgia

Intervention: T3 (Drug); Placebo (Drug)

Phase: N/A

Status: Completed

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Ian R Carroll, Principal Investigator, Affiliation: Stanford University

Summary

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.

Clinical Details

Official title: T3 for Fibromyalgia: a Pilot Double-blind Non-randomized Clinical Trial

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Visual analogue scale of pain intensity

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information

Starting date: May 2009
Last updated: June 21, 2012

Page last updated: August 23, 2015

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