Study of T3 for the Treatment of Fibromyalgia
This study has been completed.
Sponsor:
Stanford University
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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Fibromyalgia |
Drug: T3 Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | T3 for Fibromyalgia: a Pilot Double-blind Non-randomized Clinical Trial |
Resource links provided by NLM:
Further study details as provided by Stanford University:
Primary Outcome Measures:
- Visual analogue scale of pain intensity [ Time Frame: Duration of the trial ] [ Designated as safety issue: No ]
| Enrollment: | 51 |
| Study Start Date: | May 2009 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: T3 |
Drug: T3
Patients receive T3 in a dose of 25mcg and 50mcg
|
| Placebo Comparator: Placebo - sugar pill |
Drug: Placebo
Patients receive a sugar pill
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age 18-50
- Meet american college of rheumatology criteria for fibromyalgia
- at baseline report an average pain of 4 or more on a brief Pain Inventory.
- can climb 2 flights of stairs without shortness of breath.
Exclusion Criteria:
- new medication change in the last 2 months
- any cardiac disease at all
- known thyroid disease before or after thyroid screening bloodwork
- unstable medical or psychiatric disease.
- Known inflammatory or rheumatic disease other than fibromyalgia
- substance abuse in the last year
- suicidality or depression as indicated by a Beck Depression Inventory of 30 or above
- concomitant herbal medications
- multiple severe medication allergies
- the assessment of the research team that inclusion of the subject could in some way compromise the safety and validity of the study.
- diabetes
- smoking
- Known uncontrolled hypertension
- known uncontrolled hypercholesterolemia
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903877
Please refer to this study by its ClinicalTrials.gov identifier: NCT00903877
Locations
| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
Sponsors and Collaborators
Stanford University
Investigators
| Principal Investigator: | Ian R Carroll | Stanford University |
More Information
No publications provided
| Responsible Party: | Sean Mackey, Assistant Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT00903877 History of Changes |
| Other Study ID Numbers: | SU-04272009-2419, 16295 |
| Study First Received: | May 15, 2009 |
| Last Updated: | June 21, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases |
Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases |
ClinicalTrials.gov processed this record on March 01, 2015