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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
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
- Low Back Pain
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 15 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 months
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 moreSide effects data
From 2015 Phase 4 trial • 156 Patients • NCT0200222113%
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken oral steroids in the last 3 months.You have long-term kidney disease with a specific measure called eGFR less than 60.You have been diagnosed with diabetes.You are currently taking a medicine called a carbonic anhydrase inhibitor, like topiramate or zonisamide.You are currently taking cimetidine.You have ongoing weakness or numbness in your legs.You are currently taking NSAIDs.You have taken metformin in the last 6 months.You have had an allergic reaction to metformin in the past.You have had lactic acidosis in the past.You have a serious liver problem.You are currently taking certain medications for diabetes.You have been diagnosed with low back pain that is worse than pain in other parts of your body and does not spread to your legs.You have been diagnosed with conditions like rheumatoid arthritis, lupus, or other autoimmune inflammatory joint diseases.Women who could become pregnant must have a negative pregnancy test before starting the study.
Research Study Groups:
This trial has the following groups:- Group 1: Low Dose Metformin
- Group 2: Wait-List Control
- Group 3: High Dose Metformin
- Group 4: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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