Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients
Condition: Post-surgical Pain
MeSH terms: Pain, Postoperative
Intervention: CA-008; Placebo; Ketorolac; Acetaminophen; Oxycodone; Bupivacaine Hydrochloride
Intervention description: single-dose wound infiltration prior to surgical incision closure; single-dose wound infiltration prior to surgical incision closure; 30mg IV administered intraoperatively; 1000mg IV administered intraoperatively; 5mg PO prn post-surgery; 0.5% infiltration pre-surgery
Intervention MeSH terms: Acetaminophen; Ketorolac; Oxycodone; Bupivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 147.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel
      design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected
      during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the
      need for rescue medication (oxycodone).
    

Eligibility criteria:

        Inclusion Criteria:

          1. Healthy adult aged 18 - 75 years old

          2. American Society of Anesthesiology (ASA) physical Class 1, 2 or 3

          3. Planning elective Bunionectomy repair

          4. For both males and females: using an acceptable method of birth control

          5. If a female: not pregnant or breastfeeding

          6. Have a body mass index ≤ 40 kg/m2.

          7. Be willing and able to sign the informed consent form (ICF)

          8. Be able to complete study procedures and pain scales and to communicate meaningfully
             in English

          9. Be willing to undergo 17 blood draws for pharmacokinetic (PK )assessments over 24
             hours

        Exclusion Criteria:

          1. Have another painful condition, other than bunion-related pain, that may require pain
             treatment during the study period

          2. Have active skin disease or another abnormality at the anticipated site of surgery
             that could interfere with the planned surgery.

          3. Have a known allergy to chili peppers, capsaicin or the components of CA-008,
             bupivacaine HCl, ketorolac, acetaminophen or oxycodone.

          4. Have a history of significant medical, neuropsychiatric or other condition, including
             a clinically significant abnormal clinical laboratory test values

          5. Be on any medication not allowed per the protocol

          6. Within the past year have a history of illicit drug use or prescription medicine or
             alcohol abuse

          7. Have positive results on the alcohol test (breath or saliva) or urine drug screen

          8. Have previously participated in a clinical study with CA-008.

          9. Have participated in another clinical trial or used an investigational product within
             30 days or five half-lives (whichever is longer)