Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis (NCT05430230) | Clinical Trial Compass
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 range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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