NCT06245109

Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 41 Years
• Healthy volunteers: Not accepted

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 an Xray, knee MRI, brain MRI, 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.

Detailed description

This longitudinal study will screen and enroll 180 participants diagnosed with knee osteoarthritis at Northwestern University Feinberg School of Medicine. The study will last for about 20 weeks' duration with a repeat-treatment design. An equal number of participants (60 per group) will be randomly assigned in a 1:1:1 ratio, stratified by sex and current opioid use, to one of three treatment groups after they qualify to enter the study. The treatment groups will celecoxib (200 mg qd), duloxetine (60 mg qd, with an initial and final 7-day titration at 30 mg qd), or matching placebo (one capsule qd). This aim of this study is to identify specific biomarkers in individual people with knee osteoarthritis pain that will allow definition of responder phenotypes distinct for different therapeutic interventions.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DRUG	Duloxetine	60 mg, oral
DRUG	Celecoxib	200 mg, oral
DRUG	Placebo	Matching placebo, oral

Timeline

• Start date: 2024-02-26
• Primary completion: 2028-03-15
• Completion: 2028-03-15
• First posted: 2024-02-07
• Last updated: 2025-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study