Osteoarthritis, KneePhase 4NCT05430230
Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis
A Phase 4 study testing Naproxen 500 Mg in people with Osteoarthritis, Knee, run by Northwestern University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Naproxen 500 Mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Aug 2022to 1 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
- Ambulatory
- Have a cellphone and/or access to a computer and be able to utilize the eDiary as directed
- Use of medications for knee OA pain on at least 4 out of 7 days per week
- eDiary entries on at least 4 out 7 days per week during the observation period
- 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
Who cannot join
- 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
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- Use of heparin or injectable anticoagulant
- Uncontrolled hypertension
- Any medical condition which in the judgement of the investigator would make it inappropriate for the participant to enroll in the study
- Use of recreational drugs
- Fibromyalgia
- Inflammatory arthropathies of any sort
- Chronic back pain in which pain level is greater than the OA pain
- Participation in another clinical trial other than one for covid or an observational and non-interventional study
- Use of walker or other aid for walking other than a single cane
- Hip pain on the ipsilateral side equal to or greater than the knee pain in the index joint
- Index knee cannot have had previous joint replacement surgery
- Arthroscopy within the past 6 months
- Injection of hyaluronate in the index knee in the past 6 months
- Corticosteroid injection in the index knee in the past 3 months
- Injection of any biologic agent in the index in the past 12 months
- Nerve ablation for the treatment of pain in the index knee
- Any acute or chronic pain condition which would interfere with the evaluation of knee pain.
- Pregnant, nursing or planning to become pregnant during length of study
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: N of 1 Pilot Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis
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.
Read the 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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Naproxen 500 Mg, Placebo
- Keywords
- osteoarthritis, responder
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naproxen 500 MgDrug
Also called non steroidal anti inflammatory drugs (NSAID)
naproxen tablets
PlaceboDrug
lactose NF
| Study group | Role | What they receive |
|---|---|---|
| Cross-over Treatment: Initial treatment with naproxen | Experimental | 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. Receives: Drug: Naproxen 500 Mg; Drug: Placebo |
| Cross-over Treatment: Initial treatment with placebo | Experimental | 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. Receives: Drug: Naproxen 500 Mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean of one week's daily pain ratings on Numeric Pain Scale (NRS) 0-10; higher worse
daily pain will be collected by a web application and averaged over a 7day period; higher scores imply more pain
Measured: baseline to end of 14 day treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start24 Aug 2022
- Primary completionJun 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be entered into the trial and have 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 and the treatment allocation and IP will be blinded.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas J. Schnitzer, Northwestern University
- Investigators
- Thomas J Schnitzer, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05430230
- Sponsor's protocol ID
- STU00215311
- Status last verified
- Mar 2026
- First submitted
- 18 Jun 2022
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N of 1 Pilot Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05430230
- Acronym / sponsor ID
- STU00215311
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, responder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 24 Aug 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be entered into the trial and have 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 and the treatment allocation and IP will be blinded.
| Arm | Type | Receives |
|---|---|---|
| Cross-over Treatment: Initial treatment with naproxen | Experimental | Drug: Naproxen 500 Mg, Drug: PlaceboThere 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. |
| Cross-over Treatment: Initial treatment with placebo | Experimental | Drug: Naproxen 500 Mg, Drug: PlaceboThere 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naproxen 500 MgAlso: non steroidal anti inflammatory drugs (NSAID)naproxen tablets | Drug | Cross-over Treatment: Initial treatment with naproxen, Cross-over Treatment: Initial treatment with placebo |
| Placebolactose NF | Drug | Cross-over Treatment: Initial treatment with naproxen, Cross-over Treatment: Initial treatment with placebo |
Primary outcome
Mean of one week's daily pain ratings on Numeric Pain Scale (NRS) 0-10; higher worse
Time frame: baseline to end of 14 day treatment period
daily pain will be collected by a web application and averaged over a 7day period; higher scores imply more pain
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas J Schnitzer, MD, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen 500 Mg in people with Osteoarthritis, Knee, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean of one week's daily pain ratings on Numeric Pain Scale (NRS) 0-10; higher worse (time frame: baseline to end of 14 day treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.