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Pharmacokinetic and Pharmacodynamic Study of FX006 in Patients With Osteoarthritis of the Knee

NCT01487200 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-01-24

Study results available
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Summary

The purpose of this study was to evaluate the safety, pharmacokinetics and pharmacodynamics of FX006 in patients with osteoarthritis of the knee.

Conditions

  • Osteoarthritis of the Knee

Interventions

DRUG

FX006 10 mg

single 3 mL IA injection

DRUG

FX006 40 mg

single 3 mL IA injection

DRUG

FX006 60 mg

single 3 mL IA injection

DRUG

TCA IR 40

single 1 mL IA injection

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Neil Bodick, MD · Flexion Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-11-30
Completion
2012-11-30

Countries

  • Australia

Study Locations

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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 NCT01487200 on ClinicalTrials.gov