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Anti-diabetic drug

Metformin for Low Back Pain

Phase 2
Waitlist Available
Led By Gwendolyn Sowa, MD, PhD
Research Sponsored by Gwendolyn Sowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 months
Awards & highlights

Summary

This trial is testing if metformin, a diabetes medication, can help non-diabetic patients with low back pain by reducing inflammation and pain. Metformin is widely used to treat type 2 diabetes.

Eligible Conditions
  • Lower Back Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in Numeric Pain Rating Scale
Change from baseline in Oswestry Disability Index
Secondary study objectives
Change from baseline in 10 Meter Walk Test
Change from baseline in 6-item Pain Catastrophizing Scale
Change from baseline in BACPAC Minimum Dataset: Pain Outcomes Assessment
+10 more

Side effects data

From 2015 Phase 4 trial • 156 Patients • NCT02002221
13%
Nasopharyngitis
10%
Hyperhidrosis
9%
Hunger
9%
Tremor
8%
Asthenia
6%
Hypoglycaemia
1%
Femoral neck fracture
1%
Squamous cell carcinoma of the tongue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vildagliptin (LAF237)
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Wait-List ControlExperimental Treatment2 Interventions
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.
Group II: Low Dose MetforminExperimental Treatment2 Interventions
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.
Group III: High Dose MetforminExperimental Treatment1 Intervention
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.
Group IV: PlaceboPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Metformin
2006
Completed Phase 4
~2430
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Gwendolyn SowaLead Sponsor
Gwendolyn Sowa, MD, PhDPrincipal Investigator - The University of Pittsburgh
University Of Wisconsin Medical Sch (Medical School)
Northwestern University Medical Sch (Residency)

Media Library

Metformin (Anti-diabetic drug) Clinical Trial Eligibility Overview. Trial Name: NCT04055012 — Phase 2
Lower Back Pain Research Study Groups: Low Dose Metformin, Wait-List Control, High Dose Metformin, Placebo
Lower Back Pain Clinical Trial 2023: Metformin Highlights & Side Effects. Trial Name: NCT04055012 — Phase 2
Metformin (Anti-diabetic drug) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04055012 — Phase 2
~7 spots leftby Oct 2025