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Nonsteroidal Anti-inflammatory Drug

NSAIDs for Knee Osteoarthritis

Phase 4
Recruiting
Led By Thomas J Schnitzer, MD, PhD
Research Sponsored by Northwestern University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Meet ACR criteria for knee OA
Male or female >40 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to end of 14 day treatment period
Awards & highlights

Study Summary

This trial is testing if non-steroidal anti-inflammatory drugs help with pain from knee osteoarthritis.

Who is the study for?
This trial is for men and women over 40 with painful knee osteoarthritis, experiencing moderate pain levels. Participants must be willing to stop current OA pain medications, use birth control if applicable, maintain any non-drug therapies stable, and have access to a cellphone or computer for eDiary entries.Check my eligibility
What is being tested?
The study tests the effectiveness of Naproxen (an NSAID) against a placebo in managing knee osteoarthritis pain. It's designed as a pilot with four periods where participants switch between treatments and placebos without knowing which they're receiving.See study design
What are the potential side effects?
Naproxen may cause digestive issues like ulcers or bleeding, heart problems such as increased blood pressure or heart attacks, kidney problems, allergic reactions, and general discomforts like headaches or dizziness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with knee osteoarthritis.
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I am over 40 years old.
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I am on a stable dose of cannabinoids and can maintain this dose throughout the study.
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I use medication for knee pain most days of the week.
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My knee pain varies by 2 or more points on the pain scale on at least 4 different days.
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My knee pain averages between 4 and 8 out of 10.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of 14 day treatment period
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of 14 day treatment period for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean of one week's daily pain ratings on Numeric Pain Scale (NRS) 0-10; higher worse
Other outcome measures
Knee Injury and Osteoarthritis Outcome Score (KOOS) 0-100; higher better
Oswestry Disability Index (ODI) 0-50; higher is greater disability
Pain Detect Questionnaire (PDQ) 0-38; higher more neuropathic
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cross-over Treatment: Initial treatment with placeboExperimental Treatment2 Interventions
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.
Group II: Cross-over Treatment: Initial treatment with naproxenExperimental Treatment2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Naproxen
FDA approved
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Northwestern UniversityLead Sponsor
1,586 Previous Clinical Trials
917,231 Total Patients Enrolled
13 Trials studying Osteoarthritis
872 Patients Enrolled for Osteoarthritis
Thomas J Schnitzer, MD, PhDPrincipal InvestigatorNorthwestern University
10 Previous Clinical Trials
490 Total Patients Enrolled
2 Trials studying Osteoarthritis
220 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team actively seeking out participants for this experiment?

"The clinicaltrial.gov website indicates that this particular medical trial is no longer recruiting participants, as it was last edited on June 18th 2022. However, 693 other studies are open for enrollment at the current time."

Answered by AI

What adverse effects may arise from taking Naproxen 500 Mg?

"Naproxen 500 Mg has completed the fourth stage of trials, thus indicating it is approved and classified with a safety score of 3."

Answered by AI

Who else is applying?

What site did they apply to?
Northwestern University Feinberg School of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis
Thomas J. Schnitzer 2022. "Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05430230.
All > Osteoarthritis Knee > Knee Osteoarthritis
~5 spots leftby Dec 2024
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