Study of FX006 for the Treatment of Pain in Patients With Osteoarthritis of the Knee

NCT02357459 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 486

Last updated 2024-01-24

Study results available
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Summary

The purpose of this study was to assess the safety and efficacy of FX006 for the treatment of pain in patients with osteoarthritis of the knee.

Conditions

  • Osteoarthritis of the Knee

Interventions

DRUG

FX006

Single 5 mL IA injection

DRUG

Placebo

Single 5 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
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • United States
  • Australia
  • Canada
  • Denmark
  • Estonia
  • Hong Kong
  • Lithuania
  • Romania

Study Locations

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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 NCT02357459 on ClinicalTrials.gov