Active — Not RecruitingPhase 4

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

United States20 participantsStarted 2022-08-24

Plain-language 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.

Who can participate

Age range40 Years

SexALL

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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

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

What they're measuring

Mean of one week's daily pain ratings on Numeric Pain Scale (NRS) 0-10; higher worse

Timeframe: baseline to end of 14 day treatment period

Trial details

NCT IDNCT05430230

SponsorNorthwestern University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06

View on ClinicalTrials.gov More Osteoarthritis, Knee trials