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Study to Assess the Safety and Efficacy of FX006 Administered to Patients With Greater Trochanteric Bursitis

NCT04182672 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2024-01-02

Study results available
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Summary

The purpose of this study is to determine the safety and efficacy of FX006 in bursal injections and to assess the patient's impression to change in their chronic pain, following treatment.

Conditions

  • Trochanteric Bursitis

Interventions

DRUG

FX006

Subjects will be injected with the 5mL of FX006. This injection may be followed with up to 3mL of ropivacaine (depending on the capacity of the bursa), under ultrasound guidance.

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Pritish Bawa, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-12
Primary Completion
2022-12-14
Completion
2022-12-14
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 NCT04182672 on ClinicalTrials.gov