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Study in Subjects Undergoing Complete Abdominoplasty

NCT03789318 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-03-19

Study results available
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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.

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.

Sponsors & Collaborators

  • Concentric Analgesics

    lead INDUSTRY

Principal Investigators

  • Alina Beaton, MD · Lotus Clinical Research, LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2019-05-16
Completion
2019-06-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03789318 on ClinicalTrials.gov