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Antioxidant

GlyNAC for Postoperative Pain After Knee Replacement

Phase 4

Recruiting

Led By Stephen Bruehl, Ph.D.

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 50 or older

Intact cognitive status and ability to provide informed consent (based on cognitive screening with the Mini Mental State Examination)

Must not have

Diagnosis of pre-existing neuropathy

Untreated hypo/hyperthyroidism

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 4 week pre-tka assessment, and 6 weeks, 6 months and 12 months post tka (13 months)

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests if GlyNAC can reduce post-op pain & oxidative stress in knee replacement patients over 12mo.

Who is the study for?

This trial is for individuals over 50 with osteoarthritis who are experiencing significant pain and are scheduled for total knee replacement surgery. They must be able to understand and consent to the study, as well as complete questionnaires in English. People with pregnancy, vascular diseases, autoimmune disorders, cancer, neuropathy, untreated thyroid or heart conditions, certain liver or kidney issues, or other significant chronic pains are not eligible.

What is being tested?

The trial is testing whether a combination of antioxidants called GlyNAC (glycine and n-acetylcysteine) can reduce oxidative stress and prevent long-term chronic pain after knee replacement surgery. Participants will receive either GlyNAC or a placebo before and after their surgery in this randomized controlled study.

What are the potential side effects?

While specific side effects of GlyNAC aren't detailed here, common side effects may include gastrointestinal discomfort such as nausea or diarrhea. Antioxidants like N-acetylcysteine sometimes cause allergic reactions or skin rashes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 50 years old or older.

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I am mentally capable of understanding and agreeing to the trial.

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My worst pain in the last 24 hours was at least a 4 out of 10.

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I have been diagnosed with osteoarthritis.

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I am having a knee replacement surgery on one knee.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with neuropathy before.

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I have untreated thyroid issues.

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I have chronic pain not in my legs that's moderate or has been treated for over 3 months.

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I was diagnosed with CRPS before my knee replacement surgery.

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I have a disease affecting my leg blood vessels, or an inflammatory, autoimmune disorder, or cancer.

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I have heart disease that has not been treated.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 4 week pre-tka assessment, and 6 weeks, 6 months and 12 months post tka (13 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 4 week pre-tka assessment, and 6 weeks, 6 months and 12 months post tka (13 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 4 week pre-tka assessment, and 6 weeks, 6 months and 12 months post tka (13 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

Numeric Rating Scale (NRS) Rating of Worst Pain in the past 24 hours

Secondary study objectives

F2-Isoprostane/Isofuran (IsoP/IsoF) levels

Glutathione levels

Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS-JR)

+6 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: GlyNAC (combination of glycine and n-acetylcysteine)Experimental Treatment1 Intervention

GlyNAC 200 mg/kg/day (100mg glycine and 100mg N-acetyl-cysteine) will be administered orally in two divided doses each day for four weeks prior to TKA and six weeks postoperatively. The preparation will be a commercially available product of 1:1 ratio of glycine and N-acetyl-cysteine.

Group II: Placebo (alanine)Placebo Group1 Intervention

Placebo (alanine) 200 mg/kg/day will be administered orally in two divided doses each day for four weeks prior to TKA and six weeks postoperatively.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

GlyNAC (combination of glycine and n-acetylcysteine)

2014

Completed Phase 1

~20

0 / 11Eligibility criteria met