Effects of Metformin on Low Back Pain

Last updated: January 31, 2025
Sponsor: Gwendolyn Sowa
Overall Status: Terminated

Phase

2

Condition

Chronic Pain

Treatment

Placebo

Metformin

Clinical Study ID

NCT04055012
STUDY19010007
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age 18 and above

  • Diagnosed with axial low back pain (low back pain more severe than pain in otherparts of the body, without radiation of pain into the lower extremities).

  • Women of child bearing potential must have a negative serum pregnancy test atbaseline.

Exclusion

Exclusion Criteria:

  • Diagnosed with rheumatoid arthritis, lupus, other autoimmune/systemic inflammatoryarthropathies

  • 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 orbreastfeed 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

Study Design

Total Participants: 23
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
January 07, 2020
Estimated Completion Date:
December 15, 2023

Study 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 outcome measures have since been updated to reflect what was collected for the trial.

Connect with a study center

  • UPMC Kaufmann Medical Building

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • UPMC Wexford Spine Center

    Wexford, Pennsylvania 15090
    United States

    Site Not Available

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