Study in Subjects Undergoing Complete Abdominoplasty

Postsurgical Pain Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Pain, Postoperative
• Postsurgical Pain

• NCT number: NCT03789318
• Study type: Interventional
• Source: Concentric Analgesics
• Status: Completed
• Phase: Phase 2
• Start date: December 3, 2018
• Completion date: June 12, 2019