Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT04055012
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04055012
Study Brief:
Protocol Section:
NCT04055012