Osteoarthritis, Knee | Trial of Naproxen to Evaluate Various Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee
Osteoarthritis, Knee research study
What is the primary objective of this study?
This study aims to evaluate various methods of measuring pain relief in subjects who have chronic OA of the knee. After a 1 week of wash-out from existing therapy, subjects will be treated in a blinded fashion for 1 week with either naproxen (3 days at 250 mg twice a day followed by 4 days at 500 mg twice a day) or placebo. After the first week of treatment, subjects will have another week of wash-out followed by a second period of 1 week of the alternate treatment. Subjects will not be allowed to use oral non-steroidal anti-inflammatory drugs (NSAIDs) or other oral analgesics, or topical medications on their target knees during the study. Acetaminophen will be allowed as a rescue medication.
Who is eligible to participate?
Inclusion Criteria: 1. Subject able to read, comprehend and sign written Informed Consent Form 2. Subject is 21 years old or older 3. If female, should be post-menopausal or has negative urine test 4. Subject has some degree of target joint pain for the last 3 months 5. Subject has to have 3 out of six: ( )Age > 50 ( )Morning stiffness < 30 minutes ( )Crepitus on active motion ( )Bony enlargement ( )No palpable warmth of synovium 6. Subject had an X-ray of the target knee showing evidence of OA within the past 3 years 7. Target joint does not contain any type of orthopedic and/or prosthetic device 8. Subject is ambulatory 9. Subject is in good general medical and psychological health, and is capable of completing study assessments and procedures. Exclusion Criteria: 1. Subject had an x-ray of the target knee showing Kellgren-Lawrence grade 4 2. Subject has any pain syndrome that has the potential to confound the assessment of the target knee. 3. the subject has a documented history of an adverse reaction to NSAIDs or acetaminophen 4. Subject is pregnant or breast feeding 5. Subject has sitting systolic pressure > 180 mmHg or < 90mmHg, and/or a sitting diastolic pressure > 100 mmHg or < 50 mmHg at screening 6. Subject has mass body index (BMI) > 35 kg/m2. 7. Subject has a Hospital Anxiety and Depression Scale (HADS) score > 12 on either subscale or has an established history of major depressive disorder not controlled with medication 8. Subject has had an introduction of physiotherapy, acupuncture, or transcutaneous electrical nerve stimulation within 4 weeks before screening, or has no stable regimen of these modalities. 9. Subject has a clinically significant abnormalities in clinical chemistry, hematology, coagulation, or urinalysis. 10. Subject has a significant history or renal impairment 11. Subject has a positive urine drug screen for alcohol, illicit drugs or nonprescribed controlled substances 12. Subject has dermatological lesions of the target knee or ipsilateral elbow at the time of screening. 13. Subject is unable to discontinue all formulations of prior analgesics 14. Subject has received any investigational drug within 30 days prior to screening 15. Subject has a history of active peptic ulceration, gastrointestinal bleeding, esophageal, or gastric or duodenal ulcer within 3 months of screening 16. Subject has had a surgical intervention for any pain within 3 months of screening or plans for surgical intervention while in the study 17. Subject has a documented history of inflammatory arthritis, including rheumatoid arthritis. 18. Subject has received local corticosteroid injections, viscosupplementation, or arthrocentesis in the target joint within 3 months of screening 19. Subject has received oral or intramuscular corticosteroids within the past 30 days 20. Subject is involved in an ongoing or settled worker's compensation claim, disability, or litigation related to any pain problem 21. Subject had used opioids for pain more than 4 days in the week preceding screening 22. Subject has a history of alcohol or drug abuse/dependence/misuse within 2 years of screening 23. Subject has history of acute coronary syndrome, ischemic or hemorrhagic stroke, transient ischemic attack, or previous revascularization procedure to coronary or peripheral vasculature, or has a history of congestive heart failure within 5 years of screening 24. Subject has had axillary lymph nodes removed bilaterally 25. Subject has a disease-related or iatrogenic coagulopathy, or had been diagnosed with thrombocytopenia or a functional platelet disorder 26. The subject is currently on an aromatase inhibitor. 27. Subject has a history of any condition that, in the Investigator's opinion, precludes participation in the study
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:NaproxenNaproxen for 7 days (3 days at 250 mg BID followed by 4 days at 500 mg BID) during either of the 2 treatment periods.
Drug:PlaceboPlacebo for seven days given BID during either of the 2 treatment periods.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: December 2011
Completed Date: June 2012
Primary Outcome: Efficacy of naproxen vs. placebo
Study sponsors, principal investigator, and references
Principal Investigator: Stephen Wright, MD
Lead Sponsor: Analgesic Solutions