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Study of CA-008 (Vocacapsaicin) in Bunionectomy Patients

NCT03599089 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2021-08-11

Study results available
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Summary

This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone).

Conditions

  • Post-surgical Pain

Interventions

DRUG

CA-008

single-dose wound infiltration prior to surgical incision closure

DRUG

Placebo

single-dose wound infiltration prior to surgical incision closure

DRUG

Ketorolac

30mg IV administered intraoperatively

DRUG

Acetaminophen

1000mg IV administered intraoperatively

DRUG

Oxycodone

5mg PO prn post-surgery

DRUG

Bupivacaine Hydrochloride

0.5% infiltration pre-surgery

Sponsors & Collaborators

  • Concentric Analgesics

    lead INDUSTRY

Principal Investigators

  • Nancy Wu · Concentric Analgesics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2018-10-10
Completion
2018-10-23
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 NCT03599089 on ClinicalTrials.gov