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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06245109
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
41 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Duloxetine — DRUG
    60 mg, oral
  • Celecoxib — DRUG
    200 mg, oral
  • Placebo — DRUG
    Matching placebo, oral

Study Details

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.

Key Dates

Start date
Feb 26, 2024
Status verified
Apr 2026
Primary completion
Mar 15, 2028
Completion
Mar 15, 2028

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Duloxetine
    Duloxetine 60mg tablet, daily (with an initial and final 7-day titration at 30 mg, daily)
  • Active Comparator: Celecoxib
    Celecoxib 200 mg tablet, daily
  • Placebo Comparator: Placebo
    Matching placebo tablet, daily

Primary Outcome Measure

Percentage of Individuals with at least 30% Pain Response to treatment [ Time Frame: Baseline to end of first treatment period (week 6) and second treatment period (week 16) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Graeme Witte
[email protected]
312-503-4163

Find similar trials in Chicago, IL

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
Northwestern University· Chicago, IL

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