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A Phase 1 Study of Intraoperative Administration of CA-008 for the Correction of Hallux Valgus Deformity

NCT03307837 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-06-30

Study results available
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Summary

This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose, sequential-group Phase 1 study. The study will be conducted utilizing a cohort design, with sequential groups of 8 subjects. Within each dose cohort, 6 subjects will be randomized to active, and 2 will be randomized to placebo.

Conditions

  • Hallux Valgus Deformity

Interventions

DRUG

CA-008

Local administration during surgery

DRUG

Placebo

Local administration during surgery

Sponsors & Collaborators

  • Concentric Analgesics

    lead INDUSTRY

Principal Investigators

  • John Donovan, MD · Concentric Analgesics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2017-11-02
Primary Completion
2018-03-20
Completion
2018-04-25
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 NCT03307837 on ClinicalTrials.gov