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

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Description

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.

Targeted Conditions

Study Overview

Start Date
January 31, 2024
Completion Date
August 1, 2028
Enrollment
180
Date Posted
February 7, 2024
Accepts Healthy Volunteers?
No
Gender
All

Locations

Full Address
Northwestern University
Chicago, Illinois 60611, United States

Eligibility

Minimum Age (years)
40
Eligibility Criteria
Inclusion Criteria:

Male or female, age greater than 40 years, with no racial/ethnic restrictions
Meet American College of Rheumatology (ACR) criteria for knee osteoarthritis (OA)
Knee pain most days of the week for the past month
Must have average pain score for the week prior to baseline of ≥ 4 (on 1 to 10 numeric rating scale (NRS))
Must complete pain ratings on at least 4 out of 7 days prior to baseline
Must be able to 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
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

Exclusion Criteria:

Evidence of rheumatoid arthritis, ankylosing spondylitis, other inflammatory arthropathy
Functional class IV
Significant other medical disease such as uncontrolled hypertension, unstable diabetes mellitus, congestive heart failure, coronary or peripheral vascular disease, chronic obstructive lung disease, liver disease (LFT's >3x ULN) or malignancy
Current us of recreational drugs or history (in last 12 months) of alcohol or drug abuse
High dose opioid prophylaxis, as defined as > 50mg morphine equivalent/day
Any medical condition in that in the investigator's judgement may prevent the individual from completing the study or put the individual at undue risk
In the judgement of the investigator, unable or unwilling to follow protocol instructions
Intra-axial implants (e.g., spinal cord stimulators or pumps)
All exclusion criteria for magnetic resonance (MR) safety: any metallic implants, brain or skull abnormalities, tattoos on large body parts, and claustrophobia
Pregnancy
Chronic neurologic conditions, e.g., Parkinson's
Chronic renal disease
Renal insufficiency (creatine >1.5 mg/dl)
Previous history of peptic ulcer of GI bleeding
Use of anticoagulants or platelet inhibitors other than aspirin (ASA) at ≤325 mg/day
Allergy to sulfonamide drugs, duloxetine or acetaminophen
Acute myocardial infarction or coronary artery bypass graft surgery, in the past 12 months
Recent injection into the index knee of hyaluronic acid or other substance in the last 6 months, or steroid in the last 90 days
Severe lactose intolerance

Study Contact Info

Study Contact Name
Graeme Witte; Narina Simonian, BS, CCRC
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
Yes
FDA Regulated Device?
No
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.
NCTid (if applicable)
NCT06245109