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

Primary Purpose

Osteoarthritis, Knee

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Naproxen 500 Mg

Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, responder

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Northwestern University Feinberg School of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Cross-over Treatment: Initial treatment with naproxen

Cross-over Treatment: Initial treatment with placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05430230

First Posted

June 18, 2022

Last Updated

January 10, 2023

Sponsor

Northwestern University

1. Study Identification

Unique Protocol Identification Number

NCT05430230

Brief Title

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

Official Title

N of 1 Pilot Study of Nonsteroidal Anti-inflammatory Drugs in People With Painful Knee Osteoarthritis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

August 24, 2022 (Actual)

Primary Completion Date

July 2023 (Anticipated)

Study Completion Date

September 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

osteoarthritis, responder

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

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

ParticipantInvestigatorOutcomes Assessor

Masking Description

All medication will be prepared in capsules identical in appearance and weight.

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cross-over Treatment: Initial treatment with naproxen

Arm Type

Experimental

Arm Description

Arm Title

Cross-over Treatment: Initial treatment with placebo

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Naproxen 500 Mg

Other Intervention Name(s)

non steroidal anti inflammatory drugs (NSAID)

Intervention Description

naproxen tablets

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

lactose NF

Primary Outcome Measure Information:

Title

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

Description

daily pain will be collected by a web application and averaged over a 7day period; higher scores imply more pain

Time Frame

baseline to end of 14 day treatment period

Other Pre-specified Outcome Measures:

Title

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

Description

KOOS questionnaire

Time Frame

baseline to end of 14 day treatment period

Title

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

Description

PDQ

Time Frame

baseline to end of 14 day treatment period

Title

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

Description

positive and negative affect

Time Frame

baseline to end of 14 day treatment period

Title

Quantitative Sensory Testing (QST) 0-100; higher is greater pain

Description

quantitative sensory testing parameters - temporal summation

Time Frame

baseline to end of 14 day treatment period

Title

Oswestry Disability Index (ODI) 0-50; higher is greater disability

Description

Oswestry Disability Index

Time Frame

baseline to end of 14 day treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Narina Simonian

Phone

13125035780

n-simonian@northwestern.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas J Schnitzer, MD, PhD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Northwestern University Feinberg School of Medicine

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Narina Simonian

Phone

312-503-5780

n-simonian@northwestern.edu

First Name & Middle Initial & Last Name & Degree

Thomas J Schnitzer, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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