Clinical trial: Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee (NCT01688934)

Eligibility criteria:
Key Inclusion Criteria:

          1. Subjects with moderate pain due to OA of the knee as their primary pain condition.

          2. Subjects with diagnostic criteria for primary pain condition (American college of
             Rheumatology [ACR] clinical and radiographic criteria):

               -  At least 1 of the following in addition to knee pain: age >50, stiffness <30 min,
                  crepitus on active motion, and

               -  Kellgren-Lawrence (K-L) grade ≥ 2 radiographic evidence within the past 2 years.

        Key Exclusion Criteria:

          1. Subjects with chronic pain conditions other than OA of the knee as their predominant
             pain condition, including gout, pseudo gout, psoriatic arthritis, active Lyme disease,
             rheumatoid arthritis or any other inflammatory arthritis, fibromyalgia, neuropathic
             pain conditions, bursitis, or acute injury or signs of active infection in the target
             pain area.

          2. Subjects who cannot or will not agree to stop all concomitant analgesic medications,
             apart from specified protocol supplemental analgesic medications.

          3. Subjects with history of seizures within the past 5 years.

          4. Subjects who use opioids more than 4 days per week.

          5. Pain-condition-specific exclusions:

               -  Subjects who received local pain-control procedures, including intra- articular
                  steroid injection in the study knee or intramuscular steroid injection at any
                  site within 6 weeks of entering the study or hyaluronate injection in the study
                  knee within 12 weeks of entering the study.

          6. Subjects who have had arthroscopy on either knee or hip within 6 months of entering
             the study, or open surgery on either knee or hip within 12 months of entering the
             study.

          7. Active-comparator-related exclusions:

               -  Subjects who are allergic to or cannot tolerate naproxen or acetaminophen,
                  including history of NSAID-induced asthma, or nasal polyps;

               -  Subjects with history of bleeding disorders or history of documented
                  gastrointestinal ulcer disease.

        Other protocol specific inclusion/exclusion criteria may apply.
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