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Study of FX006 vs Normal Saline in Patients With Osteoarthritis of the Knee

NCT02116972 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 310

Last updated 2024-01-24

Study results available
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Summary

The purpose of this study was to assess the magnitude and duration of pain relief of a single IA injection of 2 doses (16 and 32 mg) of FX006, an extended-release formulation of TCA, relative to normal saline (placebo control).

Conditions

  • Osteoarthritis of the Knee

Interventions

DRUG

FX006 32 mg

Single 5 mL IA injection

DRUG

Placebo

Single 5 mL IA injection

DRUG

FX006 16 mg

Single 5 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
2014-04-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • United States
  • Canada

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 NCT02116972 on ClinicalTrials.gov