NCT03789318

Study in Subjects Undergoing Complete Abdominoplasty

A Phase 2, Randomized, Double-blind, Placebo-Controlled Efficacy, Pharmacokinetics and Safety Study of CA-008 in Subjects Undergoing Complete Abdominoplasty

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Concentric Analgesics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Phase 2, single center, randomized, double-blind, placebo-controlled, parallel design study of CA-008 vs. placebo in subjects undergoing an elective C-ABD under general anesthesia supplemented with a bupivacaine hydrochloride (HCl)transverse abdominis plane (TAP) block.

Detailed description

This is a Phase 2, single-center, randomized, double-blind, placebo-controlled, parallel design study evaluating up to 4 ascending dose level cohorts, each evaluating a single dose of CA-008 vs. placebo injected/instilled during an elective C-ABD. Up to 72 subjects may be randomized in 4 cohorts. For each subject, postsurgical assessments will be conducted in two parts: * Inpatient period: starts with completion of study treatment injection (T0) and continues through 96 hours (T96h). * Outpatient period: begins on discharge from the inpatient unit through various follow up visits to day 29 (D29)/week 4 (W4) after surgery. Note that additional follow up visits may occur at any time or even after D29/W4 to follow adverse events (AEs) to resolution or establishment of a new baseline.

Conditions

• Postsurgical Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-12-03
• Primary completion: 2019-05-16
• Completion: 2019-06-12
• First posted: 2018-12-28
• Last updated: 2024-03-19
• Results posted: 2022-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study