Study in Subjects Undergoing Complete Abdominoplasty

PHASE2CompletedINTERVENTIONAL
Enrollment

54

Participants

Timeline

Start Date

December 3, 2018

Primary Completion Date

May 16, 2019

Study Completion Date

June 12, 2019

Conditions
Postsurgical Pain
Interventions
DRUG

CA-008 5 mg

5 mg CA-008 reconstituted in saline.

DRUG

Placebo

Each cohort will use placebo reconstituted in saline.

DRUG

Bupivacaine Hydrochloride

0.25% administered pre-surgery

DRUG

Hydromorphone

0.02 mg/kg IV administered intraoperatively

DRUG

Fentanyl

100 mcg IV administered intraoperatively

DRUG

Acetaminophen

1000 mg IV administered intraoperatively

DRUG

Oxycodone

5-10 mg PO administered post-surgery

DRUG

CA-008 10 mg

10 mg CA-008 reconstituted in saline.

DRUG

CA-008 15 mg

15 mg CA-008 reconstituted in saline.

Trial Locations (1)

91105

Lotus Clinical Research, LLC, Pasadena

Sponsors
All Listed Sponsors
lead

Concentric Analgesics

INDUSTRY