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Study to Characterize the Local Duration of Exposure From FX006 in Patients With Osteoarthritis of the Knee

NCT02003365 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-01-24

Study results available
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Summary

The purpose of this study was to characterize the local duration of exposure of TCA for 2 doses of FX006 relative to 40 mg of TCA IR in patients with OA of the knee.

Conditions

  • Osteoarthritis of the Knee

Interventions

DRUG

FX006 10 mg

Extended-release formulation

DRUG

FX006 40 mg

Extended-release formulation

DRUG

TCA IR 40 mg

Immediate-release formulation

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Neil Bodick, MD · Flexion Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

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 NCT02003365 on ClinicalTrials.gov