Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	40 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Male or female >40 years of age. 2. Meet ACR criteria for knee OA. 3. Able and willing to provide informed consent. 4. Average weekly pain in the index knee based on daily pain assessments of ≥ 4/10 and <9/10 on an 11-point NRS scale. 5. Willing to discontinue current medications taken for OA pain. 6. For women of child-bearing potential, willing to utilize some form of birth control or abstinence during the course of the study. 7. If taking cannabinoids, have to be on a stable dose and have this maintained for the duration of the study. 8. 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. 9. Ambulatory. 10. Have a cellphone and/or access to a computer and be able to utilize the eDiary as directed. 11. Use of medications for knee OA pain on at least 4 out of 7 days per week. 12. eDiary entries on at least 4 out 7 days per week during the observation period. 13. 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:

1. History of intolerance or allergic reaction to NSAIDs. 2. Previous history of GI bleed. 3. Renal insufficiency resulting in serum creatinine > 1.5 mg/dL. 4. History of myocardial infarction in last 6 months. 5. Coexisting congestive heart failure or symptomatic atherosclerotic heart disease. 6. Use of oral anticoagulants other than aspirin ≤ 325 mg for cardiac prophylaxis. 7. Use of heparin or injectable anticoagulant. 8. Uncontrolled hypertension. 9. Any medical condition which in the judgement of the investigator would make it inappropriate for the participant to enroll in the study. 10. Use of recreational drugs. 11. Fibromyalgia. 12. Inflammatory arthropathies of any sort. 13. Chronic back pain in which pain level is greater than the OA pain. 14. Participation in another clinical trial other than one for covid or an observational and non-interventional study. 15. Use of walker or other aid for walking other than a single cane. 16. Hip pain on the ipsilateral side equal to or greater than the knee pain in the index joint. 17. Index knee cannot have had previous joint replacement surgery. 18. Arthroscopy within the past 6 months. 19. Injection of hyaluronate in the index knee in the past 6 months. 20. Corticosteroid injection in the index knee in the past 3 months. 21. Injection of any biologic agent in the index in the past 12 months. 22. Nerve ablation for the treatment of pain in the index knee. 23. Any acute or chronic pain condition which would interfere with the evaluation of knee pain. 24. Pregnant, nursing or planning to become pregnant during length of study

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05430230
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Northwestern University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Thomas J Schnitzer, MD, PhD
Principal Investigator Affiliation	Northwestern University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Osteoarthritis, Knee

Additional Details

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 the end of this washout, participants will then receive either naproxen or placebo for a further 2 week period followed again by a 2 week washout. This sequence will then be repeated (total of 4 treatment periods) such that all participants receive naproxen for 2 treatment periods and placebo for 2 treatment periods. The order of treatment will be randomized.

Arms & Interventions

Arms

Experimental: Cross-over Treatment: Initial treatment with naproxen

There will be a 4 period cross-over: 2 weeks of treatment with IP, followed by 2 weeks of washout, and this repeated 3 more times. Treatment will be such that all participants will receive 2 treatment periods with naproxen and 2 treatment periods with placebo. The order of treatment will be randomized and the treatment allocation and IP will be blinded.

Experimental: Cross-over Treatment: Initial treatment with placebo

Interventions

Drug: - Naproxen 500 Mg

naproxen tablets

Drug: - Placebo

lactose NF

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chicago, Illinois

Status

Recruiting

Address

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611

Site Contact

Narina Simonian

[email protected]

312-503-5780

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