A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee
Condition: Osteo Arthritis Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: V120083; Naproxen; Placebo
Intervention description: Capsules; Capsules; Capsules to match V120083 and/or naproxen
Intervention MeSH terms: Naproxen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 291.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Pain; Osteoarthritis Knee

Summary:

      The purpose of this study is to evaluate the analgesic efficacy of V120083 twice daily
      compared to placebo in subjects with moderate to severe chronic pain due to OA of the knee.
    

Eligibility criteria:

        Key Inclusion Criteria Include:

          1. Males and females ≥ 40 and ≤ 80 years of age with moderate to severe chronic OA pain
             of the knee (lasting several hours daily) as their predominant pain condition for at
             least 6 months prior to screening

          2. 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, morning stiffness
                  < 30 minutes, crepitus on active motion, and

               -  Kellgren-Lawrence (K-L) grade 2 or 3 radiographic evidence at the screening visit
                  as determined by a local radiologist or rheumatologist. If a radiograph is not
                  available, one must be taken and the diagnostic criteria must be confirmed before
                  randomization.

          3. Subjects whose OA pain of the index knee is not adequately treated prior to the
             screening visit:

               -  Subjects must have a self-reported average pain intensity rating of moderate or
                  severe on a verbal rating scale (ie, none, mild, moderate, and severe) over the 7
                  days prior to the screening visit

          4. The subjects must have "average pain over the last 24 hours" scores ≥ 4 and ≤ 9 on an
             11-point numerical rating scale (NRS) for the index knee on ≥ 3 consecutive days
             during the pain assessment period and come in for randomization within 96 hours after
             the latest qualifying pain score entry

          5. Subjects who are willing and able to stop taking any/all analgesic medications,
             including over-the-counter pain medications, opioids, marijuana, and topical
             analgesics for OA pain for the duration of the study, with the exception of
             study-specific rescue medication.

        Key Exclusion Criteria Include:

          1. Subjects with radiographic evidence of OA with K-L grade 0,1 or 4

          2. Subjects with chronic pain conditions other than OA of the knee as their predominant
             pain condition, including gout, pseudogout, 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

          3. Subjects scheduled for surgical interventions of the disease site or any other major
             surgery during the study conduct period

          4. Subjects with a history of a prior joint replacement of the index knee

          5. 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

          6. Subjects with a history of significant trauma to a knee, hip or shoulder within the
             previous year

          7. Subjects who have significant pain, other than or more than knee pain, including
             significant hip, back pain, that may confound the analgesic efficacy assessments of
             this study.