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Can naproxen ease knee arthritis pain? small study aims to find out

NCT ID NCT05430230

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tests whether the anti-inflammatory drug naproxen can reduce pain in people with knee osteoarthritis. Twenty participants will take naproxen or a placebo in a crossover design, meaning each person tries both treatments at different times. The study measures daily pain levels over one week for each treatment period.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Naproxen (an NSAID pain reliever)
What this could lead to
If successful, this study could show that naproxen is effective for managing knee osteoarthritis pain in some people.
What could go wrong
This is a small pilot study with only 20 participants, so results may not apply to everyone. NSAIDs can cause side effects like stomach upset or kidney issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2022

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.