Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 25, 2019

Primary Completion Date

July 2, 2019

Study Completion Date

October 22, 2019

Conditions
Pain
Interventions
DRUG

CA-008

Drug: CA-008 4.2 mg reconstituted in saline

DRUG

Ketorolac

30 mg IV at the onset of anesthesia

DRUG

Acetaminophen IV

1 g at the onset of anesthesia

DRUG

Fentanyl

100 mcg IV fentanyl administered at the onset of anesthesia and additional 50 mcg near the end of surgery

DRUG

Bupivacaine Hydrochloride

0.25% 30 mL (75 mg) prior to surgery

DRUG

Lidocaine HCl

1.5% 12 mL at the end of surgery

DRUG

Celecoxib

200 mg PO bid each day postoperative

DRUG

Acetaminophen Oral

1 g postoperative

DRUG

Lidocaine Hydrochloride

2% 15 mL at the end of surgery

DRUG

Exparel

Bupivacaine liposome injection suspension

Trial Locations (1)

91105

Lotus Clinical Research, LLC, Pasadena

Sponsors
All Listed Sponsors
lead

Concentric Analgesics

INDUSTRY

NCT03885596 - Open-Label CA-008 (Vocacapsaicin) in Bunionectomy | Biotech Hunter | Biotech Hunter