Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients
Post-surgical Pain
About this trial
This is an interventional treatment trial for Post-surgical Pain
Eligibility Criteria
Inclusion Criteria:
- Healthy adult aged 18 - 75 years old
- American Society of Anesthesiology (ASA) physical Class 1, 2 or 3
- Planning elective Bunionectomy repair
- For both males and females: using an acceptable method of birth control
- If a female: not pregnant or breastfeeding
- Have a body mass index ≤ 40 kg/m2.
- Be willing and able to sign the informed consent form (ICF)
- Be able to complete study procedures and pain scales and to communicate meaningfully in English
- Be willing to undergo 17 blood draws for pharmacokinetic (PK )assessments over 24 hours
Exclusion Criteria:
- Have another painful condition, other than bunion-related pain, that may require pain treatment during the study period
- Have active skin disease or another abnormality at the anticipated site of surgery that could interfere with the planned surgery.
- Have a known allergy to chili peppers, capsaicin or the components of CA-008, bupivacaine HCl, ketorolac, acetaminophen or oxycodone.
- Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
- Be on any medication not allowed per the protocol
- Within the past year have a history of illicit drug use or prescription medicine or alcohol abuse
- Have positive results on the alcohol test (breath or saliva) or urine drug screen
- Have previously participated in a clinical study with CA-008.
- Have participated in another clinical trial or used an investigational product within 30 days or five half-lives (whichever is longer)
Sites / Locations
- Lotus Clinical Research, LLC
- Chesapeake Research Group
- HD Research Corp
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)
CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)
CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)
Placebo
Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.
Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine.