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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430230
• Other study ID #: STU00215311
• Status: Recruiting
• Phase: Phase 4
• Start date: August 24, 2022
• Est. completion date: March 1, 2025

Study information

• Verified date: October 2023
• Source: Northwestern University
• Contact: Narina Simonian
• Phone: 13125035780
• Email: n-simonian[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 1, 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• Naproxen 500 Mg
naproxen tablets
• Placebo
lactose NF

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knee Injury and Osteoarthritis Outcome Score (KOOS) 0-100; higher better	KOOS questionnaire	baseline to end of 14 day treatment period
Other	Pain Detect Questionnaire (PDQ) 0-38; higher more neuropathic	PDQ	baseline to end of 14 day treatment period
Other	Positive and Negative Affect Schedule (PANAS) questionnaire 10-50; higher more positive or negative affect	positive and negative affect	baseline to end of 14 day treatment period
Other	Quantitative Sensory Testing (QST) 0-100; higher is greater pain	quantitative sensory testing parameters - temporal summation	baseline to end of 14 day treatment period
Other	Oswestry Disability Index (ODI) 0-50; higher is greater disability	Oswestry Disability Index	baseline to end of 14 day treatment period
Primary	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