NCT06245109 Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis
| NCT ID | NCT06245109 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Northwestern University |
| Condition | Knee Osteoarthritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-02-26 |
| Primary Completion | 2028-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 180 participants in total. It began in 2024-02-26 with a primary completion date of 2028-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: 1. Male or female, age greater than 40 years, with no racial/ethnic restrictions; 2. Meet American College of Radiology criteria for knee osteoarthritis (OA) based on radiographic evidence; 3. Knee pain most days of the week for the past month at screening; 4. Must have average pain score for the week prior to baseline of ≥ 4.0 (on a 0 to 10 Numeric Rating Scale) 5. Must complete pain ratings on at least 4 out of 7 days prior to baseline; 6. Must be able to read and speak English and be willing to read and understand instructions as well as questionnaires; 7. Must be in generally stable health; 8. Must be able to return for all clinic visits; 9. Willing to remain stable on any concomitant therapies (Transcutaneous Electrical Nerve Stimulation (TENS) unit, ice, glucosamine chondroitin, cannabinoids, etc.); 10. Must sign an informed consent document after complete explanation of the study documenting that they understand the purpose of the study, procedures to be undertaken, possible benefits, potential risks, and are willing to participate; 11. Ambulatory with or without a cane, brace(s), or walking stick (use of walker or wheelchair will be exclusionary); 12. 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; Exclusion Criteria: 1. Evidence of rheumatoid arthritis, ankylosing spondylitis, other inflammatory arthropathy; 2. Functional class IV congestive heart failure; 3. 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); 4. Current use of illicit drugs or history (in last 12 months) of alcohol or drug abuse; 5. Current cannabinoid use for knee pain; 6. High dose opioid use, as defined as \> 50mg morphine equivalent/day; 7. Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk; 8. In the judgment of the investigator, unable or unwilling to follow protocol and instructions; 9. Intra-axial implants (e.g., spinal cord stimulators or pumps); 10. Currently breastfeeding, pregnant, or planning to become pregnant during the study; 11. Chronic neurologic conditions, e.g., Parkinson's; 12. Renal insufficiency (creatinine \>1.5 mg/dl); 13. Previous history of peptic ulcer or gastrointestinal bleeding; 14. Current use of anticoagulants or platelet inhibitors other than aspirin at ≤325 mg/day; 15. Allergy to sulfonamide drugs, duloxetine, nonsteroidal anti-inflammatory drugs (NSAIDs), or acetaminophen; 16. Acute myocardial infarction or coronary artery bypass graft surgery, in the past 12 months; 17. Recent injection into the index knee of hyaluronic acid or other substance in the last 6 months, or steroid in the last 90 days; 18. Lactose allergy; 19. Current use of selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and/or tricyclic antidepressants (TCAs) at a therapeutic dose. Occasional use of these medications as a sleep aid will be allowed; however, participants will need to agree to remain on a stable dose of the medication while in the study; 20. Uncontrolled narrow-angle glaucoma; 21. Malignancy within 2 years of screening, with the exception of squamous cell carcinoma, basal cell carcinoma and prostate cancer (grade group 1); 22. Active treatment for cancer other than superficial skin cancer; or 23. Nerve ablation performed on the index knee within 12 months of screening.
Contact & Investigator
Thomas J Schnitzer, MD, PhD
PRINCIPAL INVESTIGATOR
Northwestern University
Frequently Asked Questions
Who can join the NCT06245109 clinical trial?
This trial is open to participants of all sexes, aged 41 Years or older, studying Knee Osteoarthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06245109 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06245109 currently recruiting?
Yes, NCT06245109 is actively recruiting participants. Contact the research team at graeme.witte@northwestern.edu for enrollment information.
Where is the NCT06245109 trial being conducted?
This trial is being conducted at Chicago, United States.
Who is sponsoring the NCT06245109 clinical trial?
NCT06245109 is sponsored by Northwestern University. The principal investigator is Thomas J Schnitzer, MD, PhD at Northwestern University. The trial plans to enroll 180 participants.