Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis
Northwestern University
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.
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…
Eligibility
- Age range
- 41+ years
- Sex
- All
- Healthy volunteers
- No
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 ge…
Interventions
- DrugDuloxetine
60 mg, oral
- DrugCelecoxib
200 mg, oral
- DrugPlacebo
Matching placebo, oral
Location
- Northwestern UniversityChicago, Illinois