Knee OsteoarthritisPhase 4PREDICTNCT06245109
Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis
A Phase 4 study testing Duloxetine and Celecoxib in people with Knee Osteoarthritis, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Duloxetine and Celecoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2024to 15 Mar 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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;
- Ambulatory with or without a cane, brace(s), or walking stick (use of walker or wheelchair will be exclusionary);
- 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;
Who cannot join
- 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;
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- 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;
- 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;
- Lactose allergy;
- Current use of selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), and/or tricyclic antidepressants (TCAs) at a therapeutic dose. Occasional use of these medications as a sleep aid will be allowed; however, participants will need to agree to remain on a stable dose of the medication while in the study;
- Uncontrolled narrow-angle glaucoma;
- Malignancy within 2 years of screening, with the exception of squamous cell carcinoma, basal cell carcinoma and prostate cancer (grade group 1);
- Active treatment for cancer other than superficial skin cancer; or
- Nerve ablation performed on the index knee within 12 months of screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwestern University
Chicago, Illinois, 60611
Graeme Witte, 312-503-4163, graeme.witte@northwestern.edu
About this study
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.
Read the 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
- Being tested
- Duloxetine, Celecoxib, Placebo
- Keywords
- knee oa, knee osteoarthritis, osteoarthritis, knee pain
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Also called Cymbalta
60 mg, oral
CelecoxibDrug
Also called Celebrex
200 mg, oral
PlaceboDrug
Matching placebo, oral
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine | Active comparator | Duloxetine 60mg tablet, daily (with an initial and final 7-day titration at 30 mg, daily) Receives: Drug: Duloxetine |
| Celecoxib | Active comparator | Celecoxib 200 mg tablet, daily Receives: Drug: Celecoxib |
| Placebo | Placebo comparator | Matching placebo tablet, daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to end of first treatment period (week 6) and second treatment period (week 16)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start26 Feb 2024
- Primary completion15 Mar 2028 (estimated)
- Study completion15 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Thomas J. Schnitzer, Northwestern University
- Investigators
- Thomas J Schnitzer, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06245109
- Sponsor's protocol ID
- STU00219434
- Acronym
- PREDICT
- Status last verified
- Apr 2026
- First submitted
- 29 Jan 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT06245109
- Acronym / sponsor ID
- PREDICT / STU00219434
- Conditions
- Knee Osteoarthritis
- Keywords
- knee oa, knee osteoarthritis, osteoarthritis, knee pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 15 Mar 2028 (estimated)
- Study completion
- 15 Mar 2028 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Duloxetine | Active comparator | Drug: DuloxetineDuloxetine 60mg tablet, daily (with an initial and final 7-day titration at 30 mg, daily) |
| Celecoxib | Active comparator | Drug: CelecoxibCelecoxib 200 mg tablet, daily |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo tablet, daily |
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineAlso: Cymbalta60 mg, oral | Drug | Duloxetine |
| CelecoxibAlso: Celebrex200 mg, oral | Drug | Celecoxib |
| PlaceboMatching placebo, oral | Drug | Placebo |
Primary outcome
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)
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas J Schnitzer, MD, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine and Celecoxib in people with Knee Osteoarthritis, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Graeme Witte (3125034163, graeme.witte@northwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.