- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05430230
Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis
October 25, 2023 updated by: Thomas J. Schnitzer, Northwestern University
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
20
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Narina Simonian
- Phone Number: 13125035780
- Email: n-simonian@northwestern.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- Recruiting
- Northwestern University Feinberg School of Medicine
-
Contact:
- Narina Simonian
- Phone Number: 312-503-5780
- Email: n-simonian@northwestern.edu
-
Principal Investigator:
- Thomas J Schnitzer, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cross-over Treatment: Initial treatment with naproxen
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.
|
naproxen tablets
Other Names:
lactose NF
|
Experimental: Cross-over Treatment: Initial treatment with placebo
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.
|
naproxen tablets
Other Names:
lactose NF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
baseline to end of 14 day treatment period
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee Injury and Osteoarthritis Outcome Score (KOOS) 0-100; higher better
Time Frame: baseline to end of 14 day treatment period
|
KOOS questionnaire
|
baseline to end of 14 day treatment period
|
Pain Detect Questionnaire (PDQ) 0-38; higher more neuropathic
Time Frame: baseline to end of 14 day treatment period
|
PDQ
|
baseline to end of 14 day treatment period
|
Positive and Negative Affect Schedule (PANAS) questionnaire 10-50; higher more positive or negative affect
Time Frame: baseline to end of 14 day treatment period
|
positive and negative affect
|
baseline to end of 14 day treatment period
|
Quantitative Sensory Testing (QST) 0-100; higher is greater pain
Time Frame: baseline to end of 14 day treatment period
|
quantitative sensory testing parameters - temporal summation
|
baseline to end of 14 day treatment period
|
Oswestry Disability Index (ODI) 0-50; higher is greater disability
Time Frame: baseline to end of 14 day treatment period
|
Oswestry Disability Index
|
baseline to end of 14 day treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas J Schnitzer, MD, PhD, Northwestern University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 24, 2022
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
March 1, 2025
Study Registration Dates
First Submitted
June 18, 2022
First Submitted That Met QC Criteria
June 18, 2022
First Posted (Actual)
June 24, 2022
Study Record Updates
Last Update Posted (Actual)
October 27, 2023
Last Update Submitted That Met QC Criteria
October 25, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Osteoarthritis, Knee
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Gout Suppressants
- Anti-Inflammatory Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Naproxen
Other Study ID Numbers
- STU00215311
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis, Knee
-
LifeBridge HealthMicroPort Orthopedics Inc.; Rubin Institute for Advanced OrthopedicsRecruitingKnee Osteoarthritis | Osteoarthritis, Knee | Knee Pain Chronic | Arthropathy of Knee Joint | Knee Disease | Osteoarthritis Knees Both | Osteoarthritis Knee Left | Osteoarthritis Knee RightUnited States
-
University Hospital, Clermont-FerrandSanofiCompletedKnee Osteoarthritis (Knee OA)France
-
Joseph E. BroylesCompletedDegenerative Lesion of Articular Cartilage of Knee | Degeneration; Articular Cartilage, Knee | Unilateral Primary Osteoarthritis of Knee | Osteoarthritis Knee
-
Jiangsu XinChen-Techfields Pharma Co., LTD.Completed
-
The Hong Kong Polytechnic UniversityCompleted
-
Federal University of São PauloCompletedKNEE OSTEOARTHRITISBrazil
-
Novartis PharmaceuticalsRecruitingSymptomatic Knee OsteoarthritisUnited States, Spain, Hungary, Argentina, Germany, Slovakia, Czechia, Belgium, Romania
-
University of BathUniversity of Oxford; 3D Metal Printing Ltd; Versus ArthritisRecruitingMedial Knee OsteoarthritisUnited Kingdom
-
Max Biocare Pty. Ltd.Completed
Clinical Trials on Naproxen 500 Mg
-
Organon and CoCompleted
-
POZENCompletedOsteoarthritis | Rheumatoid Arthritis | Ankylosing SpondylitisUnited States
-
NicOxCompletedHypertension | OsteoarthritisUnited States
-
Taipei Medical UniversityCompleted
-
Galapagos NVCompleted
-
NicOxCompletedOsteoarthritisUnited States
-
Primus PharmaceuticalsCompletedOsteoarthritisUnited States
-
Spero TherapeuticsRecruitingNontuberculous Mycobacterial Pulmonary Disease (NTM-PD)United States
-
University of Texas Southwestern Medical CenterNational Center for Complementary and Integrative Health (NCCIH)CompletedMajor Depressive DisorderUnited States
-
Handok Inc.Completed