An Open-label, 8-week Safety, Efficacy, and Assessment of Cooling Methods for Administration of CNTX-4975-05 for Knee OA
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: CNTX-4975-05; Lidocaine without epinephrine; ElastoGel; Breg Ice Water Pump
Intervention description: Osteoarthritis (OA) intra-articular injection of CNTX-4975-05; 15 mL lidocaine intra-articular injection; Cooling Device; Cooling Device
Intervention MeSH terms: Lidocaine; Epinephrine; Capsaicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 854.0
Sex: All
Minimum age: 40 Years
Maximum age: 95 Years
Healthy volunteers: No
Keywords: osteoarthritis; knee pain; non opioid; analgesic; capsaicin; pain; intra-articular

Summary:

      An Open-label, 8-Week Study to Compare the Comfort and Ease of Use of Five Different
      Treatment Regimens for CNTX 4975-05 Intra-articular Injection in Subjects with Chronic,
      Moderate-to-Severe Osteoarthritis Knee Pain.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Male or female subjects between 40 and 95 years of age (inclusive)

          -  Confirmation of osteoarthritis (OA) of the knee: radiography of both knees using
             standard standing films (scored by the investigator) or using the fixed flexion
             method, taken during the Screening Visit of CNTX-4975i-OA-301 or CNTX-4975i-OA-304.

          -  Confirmation of OA of the index knee: American College of Rheumatology (ACR)
             diagnostic criteria

          -  For subjects for monoarticular knee injection, the index knee must have moderate to
             severe pain at screening associated with OA, which must be stable for a minimum of 6
             months prior to Screening, as assessed by the investigator.

        These subjects may have:

          1. unilateral or bilateral OA, with the index knee having moderate to severe pain, and
             the contralateral knee having none to mild pain, OR

          2. unilateral or bilateral OA, with the index knee having moderate to severe pain and the
             other knee having had a PJR or TJR within 5 years of the Screening Visit. The knee
             with the PJR/TJR is not to be injected with CNTX-4975-05.

        For subjects for bilateral knee injection, the index knee must have moderate to severe pain
        at screening associated with OA, and greater pain in the index knee than in the
        contralateral knee. Their pain must be stable for a minimum of 6 months prior to Screening,
        as assessed by the investigator. The index knee in these subjects is the one with the worst
        pain with walking. Where both knees have equal pain with walking, then the knee on the
        subject's dominant side will be designated the index knee.

        For qualifying knee pain with walking, subjects will use an NPRS (0-10; 0=no pain, 10=worst
        possible pain) to rate their knee pain with walking (both knees, except knees with
        PJR/TJR). The PJR/TJR pain should be rated using the NPRS scale, but will not be a
        qualifying pain score.

          -  Body mass index ≤45 kg/m^2.

        Key Exclusion Criteria:

          -  Joint replacement surgery of the index knee at any time, or open surgery of the index
             knee in the past 24 months. Joint replacement of the contralateral knee is permitted
             for subjects who will not receive an injection in the contralateral (natural) knee.

          -  Prior arthroscopic surgery of the index knee within 6 months of Screening.

          -  Any painful conditions of the index knee due to joint disease other than OA. Radicular
             or referred pain involving the index knee or from joint disease other than OA
             involving the index knee, such as, but not restricted to chondromalacia patellae,
             inflammatory disease, metabolic diseases, gout/pseudogout, hemochromatosis,
             acromegaly, etc.

          -  Periarticular pain from any cause, including referred pain, bursitis, tendonitis, soft
             tissue tenderness, or subacute/acute pain from injury.

          -  Other chronic pain anywhere in the body that requires the use of chronic analgesic
             medications, including, but not limited to, local painful areas, myofascial pain
             syndromes, fibromyalgia, genetic, metabolic abnormalities, hematologic, or neuropathic
             pain.