Open-Label CA-008 (Vocacapsaicin) in Bunionectomy

Summary

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

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

Sponsors & Collaborators

• Concentric Analgesics

  lead INDUSTRY

Principal Investigators

• Nancy Wu · Concentric Analgesics

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-03-25

Primary Completion

2019-07-02

Completion

2019-10-22

FDA Drug

Yes

Countries

• United States

Study Locations