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NCT05430230 | RECRUITING | Osteoarthritis, Knee

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

Northwestern University

Information provided by (Responsible Party):

Thomas J. Schnitzer

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.

Condition or disease

Osteoarthritis, Knee

Intervention/treatment

Naproxen 500 Mg

Placebo

Phase

PHASE4

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 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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : TRIPLE
Masking Description : All medication will be prepared in capsules identical in appearance and weight.
Primary Purpose : TREATMENT
Official Title : N of 1 Pilot Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis
Actual Study Start Date : 2022-08-24
Estimated Primary Completion Date : 2024-12
Estimated Study Completion Date : 2025-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis

Location Details

NCT05430230

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How to Participate

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Locations

RECRUITING

United States, Illinois

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611