MedTrace Logo

Study to Compare Exposure of TA Following Administration of Either FX006 or TAcs in Patients With Bilateral Knee OA

NCT03378076 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-01-24

Study results available
· View outcomes & findings →

Summary

This is a randomized, open-label, parallel group study to compare systemic exposure of triamcinolone acetonide following administration into both knees of either FX006 or TAcs.

Conditions

  • Bilateral Knee Osteoarthritis

Interventions

DRUG

FX006 32 mg

Drug: Extended-release 32 mg FX006 IA injection into each knee (total 64 mg dose)

DRUG

TAcs 40 mg

Drug: Immediate-release 40mg TAcs IA injection into each knee (total 80 mg dose)

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Scott Kelley, MD · Pacira Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-06
Primary Completion
2018-03-14
Completion
2018-03-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03378076 on ClinicalTrials.gov