Study of CA-008 (Vocacapsaicin) in Total Knee Arthroplasty
Condition: Postsurgical Pain
MeSH terms: Pain, Postoperative
Intervention: CA-008; Placebo
Intervention description: 5 mg CA-008 (0.05 mg/mL), 10 mg CA-008 (0.1 mg/mL) and 15 mg CA-008 (0.15 mg/mL); Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      This is a two-part, Phase 2, multi-center, randomized, double-blind, placebo-controlled,
      parallel design study of CA-008 (vocacapsaicin) vs. placebo injected/instilled during an
      elective TKA.
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Plan to undergo an elective primary unilateral total knee arthroplasty (TKA or knee
             replacement), without collateral procedure or additional surgeries.

          2. Be a reasonably healthy adult aged 18 - 80 years old, inclusive, with a BMI ≤ 36 kg/m2
             and American Society of Anesthesiology (ASA) physical Class 1, 2 or 3 at the time of
             randomization.

          3. Males and females must abstain from intercourse, use acceptable birth control methods
             or be sterile or otherwise incapable of having children.

          4. Be willing and able to sign the informed consent form (ICF)

          5. Be willing and able to complete study procedures and pain scales and to communicate
             meaningfully in English. Be able and willing to return for outpatient follow up visits
             as required.

        Key Exclusion Criteria:

          1. In the opinion of the Investigator,

               1. have a concurrent painful condition, other than pain in the knee to be replaced,
                  that may require pain treatment during the study period.

               2. have active skin disease or other clinically significant abnormality at the
                  anticipated site of surgery that could interfere with the planned surgery.

          2. Have a known allergy to chili peppers, capsaicin or the components of CA-008,
             ropivacaine, ketorolac, acetaminophen, fentanyl, hydromorphone, morphine or oxycodone.

          3. Have significant medical, neuropsychiatric or other condition.

          4. The following are considered disallowed medications:

               1. tolerant to opioids as defined

               2. capsaicin-containing products or foods.

               3. central nervous system active agent as an analgesic adjunct medication

               4. antiarrhythmics except beta-blockers, digoxin, warfarin, lithium, or
                  aminoglycosides or other antibiotics for an infection

               5. parenteral or oral corticosteroids.

               6. antianginal, antihypertensive agent or diabetic regimen at a dose that has not
                  been stable for at least 30 days or which is not expected to remain stable while
                  participating in the study.

          5. Have positive results on the alcohol breath/saliva test indicative of alcohol abuse or
             urine drug screen indicative of illicit drug use at screening, and/or prior to
             surgery.