Clinical trial: A 12-Week Efficacy Study of Paracetamol 1000mg Sustained-release Tablets in Patients With Osteoarthritis (NCT02311881)

Eligibility criteria:
Inclusion Criteria:

          -  Male or female participants between 40 and 80 years of age

          -  Diagnosis of moderate to moderately-severe osteoarthritis (OA) of either the knee or
             hip with respect to the following:

               -  Pain in one knee/hip over 3 months immediately before screening visit

               -  Use of non steroidal anti-inflammatory drugs (NSAIDs), acetaminophen
                  (paracetamol) or any other analgesic for 3 or more days per week for at least 3
                  months prior to screening visit

               -  Clinical diagnosis of osteoarthritis of knee/hip for minimum 6 month duration
                  prior to screening visit

               -  Therapeutic benefit with acetaminophen use with a score of ≥ 1 on 5-point
                  categorical scale

               -  Radiological evidence of ≥ Grade 2 osteoarthritis according to Kellgren-Lawrence
                  radiographic criteria

          -  Increased WOMAC Pain Subscale score of at least 20 % following untreated run-in period

          -  Moderate to moderately-severe self-reported pain on a 5-point categorical scale
             following untreated run-in period

          -  Historical self-reported positive therapeutic benefit with paracetamol use for
             osteoarthritis pain relief

        Exclusion Criteria:

          -  History of surgery or major trauma to the study joint

          -  Clinically significant signs or symptoms of inflammation upon completion of run-in
             period

          -  Required ongoing use of analgesic therapy for other indications, anticoagulants,
             psychotherapeutic agents, aspirin at daily doses greater than 325 mg, statin-class
             hypolipidemic agents at doses that have not been stabilized, or other treatments know
             to interfere with pain perception

          -  History of hepatic or renal or liver or biliary disease or gastrointestinal surgery

          -  Participants with alanine aminotransferase (ALT) >2 times Upper Limit Normal (2xULN)
             and bilirubin > 1.5 times Upper Limit Normal (1.5xULN) (However, if direct bilirubin
             is <35% and fractioned, isolated bilirubin >1.5xULN is acceptable)

          -  Other arthritis type, fibromyalgia or collagen vascular disease or secondary OA of
             study joint or chronic pain condition
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment