Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

Completed · Phase 2 · Has a placebo group

Conditions studied: Post-surgical Pain

In brief

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).

Key facts

Study ID

NCT03599089

Run by

Concentric Analgesics

People needed

147

Starts

2018-07-09

Expected to finish

2018-10-23

Last updated by the study team

2021-08-11

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Lotus Clinical Research, LLC — Pasadena, California, United States
• Chesapeake Research Group — Pasadena, Maryland, United States
• HD Research Corp — Houston, Texas, United States

Full record on ClinicalTrials.gov

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