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Study to Evaluate the Efficacy and Safety of FX006 in Patients With Hip Osteoarthritis

NCT03793010 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-01-24

Study results available
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Summary

This is a two-part, multi-center, randomized, double-blind, placebo-controlled, parallel-group study in patients with hip OA. Approximately 70 patients will be enrolled in Part I and approximately 440 patients will be enrolled in Part II of the study. In each part, patients will be randomized to one of two treatment groups (1:1) and treated with a single IA injection of either 32 mg FX006 or normal saline.

Conditions

  • Osteoarthritis, Hip

Interventions

DRUG

FX006

Single Intra-articular injection

DRUG

Normal saline

Single Intra-articular injection

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    lead INDUSTRY

Principal Investigators

  • Scott Kelley, MD · Pacira Pharmaceuticals, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-12
Primary Completion
2019-08-07
Completion
2019-08-07
FDA Drug
Yes

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 NCT03793010 on ClinicalTrials.gov