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

NCT05430230 | Active Not Recruiting Phase 4 FDA Drug

• 1 other identifier: STU00215311
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis, responder

Outcome Measures

Primary Outcomes (1)

• 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

  baseline to end of 14 day treatment period

Other Outcomes (5)

• Knee Injury and Osteoarthritis Outcome Score (KOOS) 0-100; higher better

  baseline to end of 14 day treatment period

• Pain Detect Questionnaire (PDQ) 0-38; higher more neuropathic

  baseline to end of 14 day treatment period

• Positive and Negative Affect Schedule (PANAS) questionnaire 10-50; higher more positive or negative affect

  baseline to end of 14 day treatment period

Study Arms (2)

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.

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.

Drug: Naproxen 500 Mg; Drug: Placebo

Interventions

Naproxen 500 Mg DRUG

naproxen tablets

Also known as: non steroidal anti inflammatory drugs (NSAID)

Cross-over Treatment: Initial treatment with naproxen; Cross-over Treatment: Initial treatment with placebo

Placebo DRUG

lactose NF

Cross-over Treatment: Initial treatment with naproxen; Cross-over Treatment: Initial treatment with placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Naproxen

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Thomas J Schnitzer, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All medication will be prepared in capsules identical in appearance and weight.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 18, 2022
• First Posted: June 24, 2022
• Study Start: August 24, 2022
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)