Status:
ACTIVE_NOT_RECRUITING
Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis
Lead Sponsor:
Northwestern University
Conditions:
Osteoarthritis, Knee
Eligibility:
All Genders
40+ years
Phase:
PHASE4
Brief Summary
This is a pilot study with a 4-period double-cross-over design evaluating a treatment with non-steroidal anti-inflammatory drugs (NSAIDs) in people with painful knee osteoarthritis.
Detailed Description
Once screened and found eligible, participants will be entered into an initial blinded 2-week treatment period of either naproxen or placebo and then entered into an open washout period of 2 weeks. At...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Male or female \>40 years of age
- Meet ACR criteria for knee OA
- Able and willing to provide informed consent
- Average weekly pain in the index knee based on daily pain assessments of ≥ 4/10 and \<9/10 on an 11-point NRS scale
- Willing to discontinue current medications taken for OA pain
- For women of child-bearing potential, willing to utilize some form of birth control or abstinence during the course of the study
- If taking cannabinoids, have to be on a stable dose and have this maintained for the duration of the study
- If receiving physical therapy or any non-pharmacologic modality(ies) for OA, these need to continue and remain stable for the duration of the study
- Ambulatory
- Have a cellphone and/or access to a computer and be able to utilize the eDiary as directed
- Use of medications for knee OA pain on at least 4 out of 7 days per week
- eDiary entries on at least 4 out 7 days per week during the observation period
- Sub-Group Criterion (≥12 participants): Variability of average daily pain in the index knee during the observation period of ≥ 2 points on the NRS scale on at least 4 occasions
- Exclusion criteria:
- History of intolerance or allergic reaction to NSAIDs
- Previous history of GI bleed
- Renal insufficiency resulting in serum creatinine \> 1.5 mg/dL
- History of myocardial infarction in last 6 months
- Coexisting congestive heart failure or symptomatic atherosclerotic heart disease
- Use of oral anticoagulants other than aspirin ≤ 325 mg for cardiac prophylaxis
- Use of heparin or injectable anticoagulant
- Uncontrolled hypertension
- Any medical condition which in the judgement of the investigator would make it inappropriate for the participant to enroll in the study
- Use of recreational drugs
- Fibromyalgia
- Inflammatory arthropathies of any sort
- Chronic back pain in which pain level is greater than the OA pain
- Participation in another clinical trial other than one for covid or an observational and non-interventional study
- Use of walker or other aid for walking other than a single cane
- Hip pain on the ipsilateral side equal to or greater than the knee pain in the index joint
- Index knee cannot have had previous joint replacement surgery
- Arthroscopy within the past 6 months
- Injection of hyaluronate in the index knee in the past 6 months
- Corticosteroid injection in the index knee in the past 3 months
- Injection of any biologic agent in the index in the past 12 months
- Nerve ablation for the treatment of pain in the index knee
- Any acute or chronic pain condition which would interfere with the evaluation of knee pain.
- Pregnant, nursing or planning to become pregnant during length of study
Exclusion
Key Trial Info
Start Date :
August 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05430230
Start Date
August 24 2022
End Date
September 1 2026
Last Update
February 19 2025
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611