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

NCT ID: NCT05430230

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-24
• Study Completion Date: 2026-09-01

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.

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Naproxen 500 Mg

Intervention Type: DRUG

naproxen tablets

Placebo

Intervention Type: DRUG

lactose NF

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.

Group Type: EXPERIMENTAL

Naproxen 500 Mg

Intervention Type: DRUG

naproxen tablets

Placebo

Intervention Type: DRUG

lactose NF

Interventions

Naproxen 500 Mg

naproxen tablets

Intervention Type: DRUG

Placebo

lactose NF

Intervention Type: DRUG

Other Intervention Names

non steroidal anti inflammatory drugs (NSAID)

Eligibility Criteria

Inclusion Criteria

1. Male or female >40 years of age

2. Meet ACR criteria for knee OA

3. Able and willing to provide informed consent

4. Average weekly pain in the index knee based on daily pain assessments of ≥ 4/10 and <9/10 on an 11-point NRS scale

5. Willing to discontinue current medications taken for OA pain

6. For women of child-bearing potential, willing to utilize some form of birth control or abstinence during the course of the study

7. If taking cannabinoids, have to be on a stable dose and have this maintained for the duration of the study

8. 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

9. Ambulatory

10. Have a cellphone and/or access to a computer and be able to utilize the eDiary as directed

11. Use of medications for knee OA pain on at least 4 out of 7 days per week

12. eDiary entries on at least 4 out 7 days per week during the observation period

13. 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

1. History of intolerance or allergic reaction to NSAIDs

2. Previous history of GI bleed

3. Renal insufficiency resulting in serum creatinine > 1.5 mg/dL

4. History of myocardial infarction in last 6 months

5. Coexisting congestive heart failure or symptomatic atherosclerotic heart disease

6. Use of oral anticoagulants other than aspirin ≤ 325 mg for cardiac prophylaxis

7. Use of heparin or injectable anticoagulant

8. Uncontrolled hypertension

9. Any medical condition which in the judgement of the investigator would make it inappropriate for the participant to enroll in the study

10. Use of recreational drugs

11. Fibromyalgia

12. Inflammatory arthropathies of any sort

13. Chronic back pain in which pain level is greater than the OA pain

14. Participation in another clinical trial other than one for covid or an observational and non-interventional study

15. Use of walker or other aid for walking other than a single cane

16. Hip pain on the ipsilateral side equal to or greater than the knee pain in the index joint

17. Index knee cannot have had previous joint replacement surgery

18. Arthroscopy within the past 6 months

19. Injection of hyaluronate in the index knee in the past 6 months

20. Corticosteroid injection in the index knee in the past 3 months

21. Injection of any biologic agent in the index in the past 12 months

22. Nerve ablation for the treatment of pain in the index knee

23. Any acute or chronic pain condition which would interfere with the evaluation of knee pain.

24. Pregnant, nursing or planning to become pregnant during length of study

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Thomas J. Schnitzer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas J Schnitzer, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Countries

United States

Other Identifiers

STU00215311

Identifier Type: -

Identifier Source: org_study_id