Status:
TERMINATED
Effects of Metformin on Low Back Pain
Lead Sponsor:
Gwendolyn Sowa
Conditions:
Low Back Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of the current study is to determine the effects of metformin in non-diabetic patients with low back pain, and identify novel targets for future treatments
Detailed Description
Outcome measures were updated after the initial submission to clinicaltrials.gov. The outcomes were changed in the Institutional Review Board protocol but not updated on clinicaltrials.gov. These outc...
Eligibility Criteria
Inclusion
- Age 18 and above
- 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
- Diagnosed with rheumatoid arthritis, lupus, other autoimmune/systemic inflammatory arthropathies
- 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
Key Trial Info
Start Date :
January 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2023
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04055012
Start Date
January 7 2020
End Date
December 15 2023
Last Update
February 21 2025
Active Locations (2)
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1
UPMC Kaufmann Medical Building
Pittsburgh, Pennsylvania, United States, 15213
2
UPMC Wexford Spine Center
Wexford, Pennsylvania, United States, 15090