Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis (NCT06245109) | Clinical Trial Compass
RecruitingPhase 4
Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis
United States180 participantsStarted 2024-02-26
Plain-language summary
This is a clinical trial of people who have pain due to knee osteoarthritis at Northwestern University Feinberg School of Medicine. The study will last for about 20 weeks. 180 qualified participants will be randomly assigned in a 1:1:1 ratio (60 participants per group) to one of three treatment groups: duloxetine, celecoxib, or placebo. Participants will have a knee Xray, (optional) MRIs of the brain and knee, blood draws, pain sensitivity testing, and asked to fill out questionnaires. The purpose of this study is to try to predict which participants will respond to the treatment.
Who can participate
Age range41 Years
SexALL
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Inclusion criteria
✓. Male or female, age greater than 40 years, with no racial/ethnic restrictions;
✓. Meet American College of Radiology criteria for knee osteoarthritis (OA) based on radiographic evidence;
✓. Knee pain most days of the week for the past month at screening;
✓. Must have average pain score for the week prior to baseline of ≥ 4.0 (on a 0 to 10 Numeric Rating Scale)
✓. Must complete pain ratings on at least 4 out of 7 days prior to baseline;
✓. Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires;
✓. Must be in generally stable health;
✓. Must be able to return for all clinic visits;
Exclusion criteria
✕2. Glucagon-like peptide 1 (GLP-1) agonists or other weight-loss treatment permitted if started more than 3 months prior to screening with no significant change in weight (+/- 11 lbs) over the past 30 days;
What they're measuring
1
Percentage of Individuals with at least 30% Pain Response to treatment
Timeframe: Baseline to end of first treatment period (week 6) and second treatment period (week 16)
✕. Evidence of rheumatoid arthritis, ankylosing spondylitis, other inflammatory arthropathy;
✕. Functional class IV congestive heart failure;
✕. Significant other medical disease such as uncontrolled hypertension, untreated diabetes mellitus, coronary or peripheral vascular disease, chronic obstructive lung disease, or liver disease (liver function tests \> upper limit of normal);
✕. Current use of illicit drugs or history (in last 12 months) of alcohol or drug abuse;
✕. Current cannabinoid use for knee pain;
✕. High dose opioid use, as defined as \> 50mg morphine equivalent/day;
✕. Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;