Trial of Naproxen to Evaluate Various Methods of Measuring Analgesic Effect in Osteoarthritis Pain of the Knee

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

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.

Key facts

Study ID: NCT01557816
Run by: Analgesic Solutions
People needed: 70
Starts: 2011-12-01
Expected to finish: 2012-06-01
Last updated by the study team: 2012-03-22

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Subject able to read, comprehend and sign written Informed Consent Form
Subject is 21 years old or older
If female, should be post-menopausal or has negative urine test
Subject has some degree of target joint pain for the last 3 months
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
Subject had an X-ray of the target knee showing evidence of OA within the past 3 years
Target joint does not contain any type of orthopedic and/or prosthetic device
Subject is ambulatory
Subject is in good general medical and psychological health, and is capable of completing study assessments and procedures.

You may not qualify if…

Subject had an x-ray of the target knee showing Kellgren-Lawrence grade 4
Subject has any pain syndrome that has the potential to confound the assessment of the target knee.
the subject has a documented history of an adverse reaction to NSAIDs or acetaminophen
Subject is pregnant or breast feeding
Subject has sitting systolic pressure > 180 mmHg or < 90mmHg, and/or a sitting diastolic pressure > 100 mmHg or < 50 mmHg at screening
Subject has mass body index (BMI) > 35 kg/m2.
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
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.
Subject has a clinically significant abnormalities in clinical chemistry, hematology, coagulation, or urinalysis.
Subject has a significant history or renal impairment
Subject has a positive urine drug screen for alcohol, illicit drugs or nonprescribed controlled substances
Subject has dermatological lesions of the target knee or ipsilateral elbow at the time of screening.
Subject is unable to discontinue all formulations of prior analgesics
Subject has received any investigational drug within 30 days prior to screening
Subject has a history of active peptic ulceration, gastrointestinal bleeding, esophageal, or gastric or duodenal ulcer within 3 months of screening
Subject has had a surgical intervention for any pain within 3 months of screening or plans for surgical intervention while in the study
Subject has a documented history of inflammatory arthritis, including rheumatoid arthritis.
Subject has received local corticosteroid injections, viscosupplementation, or arthrocentesis in the target joint within 3 months of screening
Subject has received oral or intramuscular corticosteroids within the past 30 days
Subject is involved in an ongoing or settled worker's compensation claim, disability, or litigation related to any pain problem
Subject had used opioids for pain more than 4 days in the week preceding screening
Subject has a history of alcohol or drug abuse/dependence/misuse within 2 years of screening
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
Subject has had axillary lymph nodes removed bilaterally
Subject has a disease-related or iatrogenic coagulopathy, or had been diagnosed with thrombocytopenia or a functional platelet disorder

Where it is running

Analgesic Solutions — Natick, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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