Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

Concentric Analgesics

Status and phase: Completed; Phase 2

Conditions: Post-surgical Pain

Treatments: Drug: Acetaminophen; Drug: Oxycodone; Drug: Ketorolac; Drug: CA-008; Drug: Placebo; Drug: Bupivacaine Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT03599089

CA-PS-201

Details and patient eligibility

About

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).

Full description

Primary Objective:

To evaluate the efficacy of a single intraoperative administration of CA- 008 vs placebo in subjects undergoing an elective Bunionectomy .

Secondary Objectives

• To evaluate the safety and tolerability of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy.
• To evaluate the PK profile of a single intraoperative administration of CA-008 vs. placebo in subjects undergoing an elective Bunionectomy .
• To explore the efficacy of various doses of CA-008 administered intraoperatively in subjects undergoing an elective Bunionectomy .

Enrollment: 147 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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147 participants in 4 patient groups, including a placebo group

CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration)

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine Hydrochloride

Drug: Acetaminophen

Drug: CA-008

Drug: Oxycodone

Drug: Ketorolac

CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration)

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine Hydrochloride

Drug: Acetaminophen

Drug: CA-008

Drug: Oxycodone

Drug: Ketorolac

CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration)

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine Hydrochloride

Drug: Acetaminophen

Drug: CA-008

Drug: Oxycodone

Drug: Ketorolac

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine Hydrochloride

Drug: Acetaminophen

Drug: Placebo

Drug: Oxycodone

Drug: Ketorolac