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

NCT06245109 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: STU00219434
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Keywords

knee oa; knee osteoarthritis; osteoarthritis; knee pain

Outcome Measures

Primary Outcomes (1)

• Percentage of Individuals with at least 30% Pain Response to treatment

  At least 30% improvement from baseline in "weekly average daily pain" measured using a numeric rating scale (0-10) with 0 = no pain and 10 = worst pain

  Baseline to end of first treatment period (week 6) and second treatment period (week 16)

Study Arms (3)

Duloxetine

ACTIVE COMPARATOR

Duloxetine 60mg tablet, daily (with an initial and final 7-day titration at 30 mg, daily)

Drug: Duloxetine

Celecoxib

ACTIVE COMPARATOR

Celecoxib 200 mg tablet, daily

Drug: Celecoxib

Placebo

PLACEBO COMPARATOR

Matching placebo tablet, daily

Drug: Placebo

Interventions

Duloxetine DRUG

60 mg, oral

Also known as: Cymbalta

Duloxetine

Celecoxib DRUG

200 mg, oral

Also known as: Celebrex

Celecoxib

Placebo DRUG

Matching placebo, oral

Placebo

Eligibility Criteria

• Age: 41 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age greater than 40 years, with no racial/ethnic restrictions;
• Meet American College of Radiology criteria for knee osteoarthritis (OA) based on radiographic evidence;
• Knee pain most days of the week for the past month at screening;
• Must have average pain score for the week prior to baseline of ≥ 4.0 (on a 0 to 10 Numeric Rating Scale)
• Must complete pain ratings on at least 4 out of 7 days prior to baseline;
• Must be able to read and 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;
• Willing to remain stable on any concomitant therapies (Transcutaneous Electrical Nerve Stimulation (TENS) unit, ice, glucosamine chondroitin, cannabinoids, etc.);
• 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;
• 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;

You may not qualify if:

• Evidence of rheumatoid arthritis, ankylosing spondylitis, other inflammatory arthropathy;
• Functional class IV congestive heart failure;
• 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);
• Current use of illicit drugs or history (in last 12 months) of alcohol or drug abuse;
• Current cannabinoid use for knee pain;
• High dose opioid use, as defined as \> 50mg morphine equivalent/day;
• Any medical condition that in the investigator's judgment may prevent the individual from completing the study or put the individual at undue risk;
• In the judgment of the investigator, unable or unwilling to follow protocol and instructions;
• Intra-axial implants (e.g., spinal cord stimulators or pumps);
• Currently breastfeeding, pregnant, or planning to become pregnant during the study;
• Chronic neurologic conditions, e.g., Parkinson's;
• Renal insufficiency (creatinine \>1.5 mg/dl);
• Previous history of peptic ulcer or gastrointestinal bleeding;
• Current use of anticoagulants or platelet inhibitors other than aspirin at ≤325 mg/day;
• Allergy to sulfonamide drugs, duloxetine, nonsteroidal anti-inflammatory drugs (NSAIDs), or acetaminophen;

Sponsors & Collaborators

• Northwestern University: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Duloxetine Hydrochloride; Celecoxib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Pyrazoles; Azoles

Study Officials

• Thomas J Schnitzer, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Graeme Witte

CONTACT

3125034163; graeme.witte@northwestern.edu

Narina Simonian, BS, CCRC

CONTACT

3125035780; n-simonian@northwestern.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Synopsis of study design: The goal of this study is to identify predictors of treatment response, using quantitative sensory testing (QST), neuroimaging, and patient-reported outcome measures (PROs).

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: February 7, 2024
• Study Start: February 26, 2024
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 15, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

US (1)