Knee Osteoarthritis study: Duloxetine vs Celecoxib
Official title Brain-Based and Clinical Phenotyping of Pain Pharmacotherapy in Knee Osteoarthritis
ClinicalTrials.gov ID: NCT06245109
What this study is testing
What is Duloxetine?
This is an investigational oral medicine being studied to see if it helps with pain from knee osteoarthritis. It is designed to affect chemicals in the brain and spinal cord that help control pain signals.
Also referred to as Cymbalta.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to find out if brain scans and other tests can help doctors predict which patients will get relief from specific pain medications.
- Who it's for
- People who have pain caused by knee osteoarthritis.
- What's involved
- Participants will be randomly assigned to take duloxetine, celecoxib, or a placebo. They will also have knee X-rays, optional brain and knee MRIs, blood draws, pain sensitivity tests, and fill out questionnaires.
- Time commitment
- The study lasts about 20 weeks and requires visits for tests and check-ins.
- Phase 4: studies an already-approved treatment
- Time commitment: about 20 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 41 and older
You may be able to join 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;
You likely can't join 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...
- 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;
See the full eligibility criteria
- 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...
- 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;
- 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 \>...
- 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;
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Chicago, Illinois, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 20 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 41 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Chicago, Illinois, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.