NCT03885596

Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

An Open-Label Study of Intraoperative CA-008 Administration in Subjects Undergoing Bunionectomy

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Concentric Analgesics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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).

Conditions

• Pain

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-03-25
• Primary completion: 2019-07-02
• Completion: 2019-10-22
• First posted: 2019-03-21
• Last updated: 2021-10-27
• Results posted: 2021-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study