Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

Concentric Analgesics

Status and phase: Completed; Phase 2

Conditions: Pain

Treatments: Drug: CA-008; Drug: Acetaminophen Oral; Drug: Celecoxib; Drug: Ketorolac; Drug: Exparel; Drug: Acetaminophen IV; Drug: Fentanyl; Drug: Lidocaine Hydrochloride; Drug: Bupivacaine Hydrochloride; Drug: Lidocaine HCl

Study type: Interventional

Funder types: Industry

Identifiers

NCT03885596

CA-PS-205

Details and patient eligibility

About

A Phase 2, open-label study of CA-008 to evaluate post-surgical pain control with CA-008.

Full description

This is a Phase 2, single-center, open-label study evaluating a single dose of CA-008 4.2 mg administered with different standard-of-care anesthetic regimens during an elective unilateral transpositional first metatarsal osteotomy for the correction of hallux valgus deformity (bunionectomy).

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Healthy adult aged 18 - 65 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 ≤ 36 kg/m2

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 study medications.
4. Have a history of significant medical, neuropsychiatric or other condition, including a clinically significant abnormal clinical laboratory test values
5. Have positive results on the alcohol test (breath or saliva) or urine drug screen.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

CA-008 Cohort 1

Experimental group

Description:

CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block followed by a sciatic (popliteal) nerve block.

Treatment:

Drug: Fentanyl

Drug: Bupivacaine Hydrochloride

Drug: Lidocaine HCl

Drug: Acetaminophen Oral

Drug: Acetaminophen IV

Drug: CA-008

Drug: Celecoxib

Drug: Ketorolac

CA-008 Cohort 2

Experimental group

Description:

CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.

Treatment:

Drug: Fentanyl

Drug: Lidocaine Hydrochloride

Drug: Bupivacaine Hydrochloride

Drug: Acetaminophen Oral

Drug: Acetaminophen IV

Drug: CA-008

Drug: Celecoxib

Drug: Ketorolac

CA-008 Cohort 3

Experimental group

Description:

CA-008 4.2 mg reconstituted in saline All subjects received monitored anesthesia care (MAC) and a Mayo block.

Treatment:

Drug: Fentanyl

Drug: Lidocaine Hydrochloride

Drug: Bupivacaine Hydrochloride

Drug: Acetaminophen IV

Drug: CA-008

Drug: Ketorolac

Exparel

Active Comparator group

Description:

106 mg \[8 mL of the 133 mg/10 mL suspension\] only All subjects received monitored anesthesia care (MAC) and a Mayo block.

Treatment:

Drug: Exparel

Drug: Fentanyl

Drug: Lidocaine Hydrochloride

Drug: Bupivacaine Hydrochloride

Drug: Acetaminophen IV

Drug: Ketorolac