What side effects are associated with this type of intervention?

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), commonly used to treat osteoarthritis, are associated with several side effects. Gastrointestinal issues such as ulcers and bleeding are common, especially with long-term use. Cardiovascular risks, including increased chances of myocardial infarction, are also noted, particularly with COX-2 inhibitors like celecoxib. Renal side effects, such as kidney damage, can occur, and patients with pre-existing conditions should use NSAIDs cautiously. To mitigate these risks, NSAIDs are often prescribed at the lowest effective dose for the shortest duration possible.

What prior FDA approvals exist?

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) have been commonly used for the treatment of osteoarthritis, focusing on the inhibition of cyclooxygenase (COX) enzymes to reduce pain and inflammation. Drugs such as diclofenac and etoricoxib have been approved and are used based on their efficacy in pain relief. However, these drugs come with safety concerns, including gastrointestinal and cardiovascular risks. Selective COX-2 inhibitors like celecoxib were developed to minimize gastrointestinal side effects but have been associated with increased cardiovascular risk. Due to these safety concerns, the use of NSAIDs is often tailored to individual patient profiles, balancing efficacy with potential adverse effects.

What other types of research exist?

Promising novel alternatives to NSAIDs for osteoarthritis treatment include intra-articular corticosteroids like triamcinolone, dietary supplements such as Curcuma longa (turmeric) extract and Boswellia extract, and potential disease-modifying pharmacological therapeutics targeting specific inflammatory pathways, such as TGF-β and Wnt signaling inhibitors. These alternatives have shown efficacy in reducing pain and inflammation in OA patients.

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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

Must not have

Nerve ablation for the treatment of pain in the index knee

Arthroscopy within the past 6 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to end of 14 day treatment period

Awards & highlights

Pivotal Trial

Approved for 10 Other Conditions

Drug Has Already Been Approved

All Individual Drugs Already Approved

Summary

This trial is testing naproxen, a common pain reliever, in people with painful knee osteoarthritis. Naproxen helps reduce swelling and pain by blocking certain chemicals in the body. Participants will receive naproxen to compare its effects. Naproxen has been shown to be an effective and well-tolerated drug for the treatment of osteoarthritis of the hip and knee in previous studies.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a nerve ablation for knee pain.

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I had a knee scope surgery within the last 6 months.

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I use a walker or more than one cane to help me walk.

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My hip pain is as bad or worse than my knee pain on the same side.

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My affected knee has not had a joint replacement.

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I don't have any pain conditions that would affect my knee pain assessment.

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I have had a gastrointestinal bleed in the past.

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I have not had a heart attack in the last 6 months.

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I have heart failure or heart disease with symptoms.

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My kidney function is low with creatinine over 1.5 mg/dL.

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I am taking blood thinners other than low-dose aspirin for heart protection.

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I am using heparin or another injectable blood thinner.

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I have been diagnosed with fibromyalgia.

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My high blood pressure is not under control.

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I have a type of inflammatory joint disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of 14 day treatment period

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean of one week's daily pain ratings on Numeric Pain Scale (NRS) 0-10; higher worse

Other study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Naproxen

FDA approved

Placebo

1995

Completed Phase 3

~2670

0 / 21Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) are commonly used to treat Osteoarthritis (OA) by inhibiting cyclooxygenase (COX) enzymes, specifically COX-1 and COX-2. This inhibition reduces the production of prostaglandins, which are responsible for mediating inflammation, pain, and fever. By lowering prostaglandin levels, NSAIDs help to alleviate pain and reduce inflammation, which is crucial for OA patients to manage their symptoms effectively, improve their quality of life, and maintain physical activity.

[Comparative efficacy of antalgesics and non-steroidal anti-inflammatory drugs].