Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
23 participants
INTERVENTIONAL
2020-01-07
2023-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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High Dose Metformin
High Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 2 tabs per day (1,000mg) for the first week then increase to 3 tabs per day (1,500mg) for the remaining 6 months.
Metformin
500mg tabs of Metformin Extended Release
Low Dose Metformin
Low Dose Metformin Group (n=100). Subjects will receive metformin and will be instructed to take 1 tab per day (1 metformin tab (500mg) for 6 months.
Metformin
500mg tabs of Metformin Extended Release
Placebo
Placebo Group (n=100). Subjects will receive placebo and will be instructed to take either 2 tabs per day for the first week then increase to 3 tabs per day for the remaining 6 months OR take 1 placebo tab for 6 months.
Placebo
Placebo Tabs
Wait-List Control
Control Group (n=100). Subjects will be told that they are in the wait-list control group. They will have a 3 month "waiting period" before they will be randomized again to a treatment group. They will be randomized to one of the previous groups.
Metformin
500mg tabs of Metformin Extended Release
Placebo
Placebo Tabs
Interventions
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Metformin
500mg tabs of Metformin Extended Release
Placebo
Placebo Tabs
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with axial low back pain (low back pain more severe than pain in other parts of the body, without radiation of pain into the lower extremities).
* Women of child bearing potential must have a negative serum pregnancy test at baseline.
Exclusion Criteria
* Progressive lower extremity weakness or numbness
* Recent oral steroid use (within last 3 months)
* NSAID use
* Chronic kidney disease (eGFR \<60)
* Diagnosis of diabetes mellitus
* Subjects must not be pregnant or breastfeeding, or planning to become pregnant or breastfeed during the course of the trial
* Unable to take an oral medication in a non crushable pill form
* Taking metformin presently or within the last 6 months
* History of allergy to metformin
* History of lactic acidosis
* Severe Hepatic dysfunction
* Currently taking a diabetic medication such as sitagliptin, saxagliptin, linagliptin, alogliptin, sitagliptin with metformin
* Currently taking a Carbonic anhydrase inhibitor such as topiramate, zonisamide, acetazolamide, dichlorphenamide, methazolamide
* Currently taking cimetidine
18 Years
ALL
No
Sponsors
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Gwendolyn Sowa
OTHER
Responsible Party
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Gwendolyn Sowa
Professor and Chair Department of Physical Medicine and Rehabilitation
Principal Investigators
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Gwendolyn Sowa, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Pittsburgh
Locations
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UPMC Kaufmann Medical Building
Pittsburgh, Pennsylvania, United States
UPMC Wexford Spine Center
Wexford, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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STUDY19010007
Identifier Type: -
Identifier Source: org_study_id
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