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Study to Evaluate the Efficacy and Safety of FX006 in Patients With Glenohumeral Osteoarthritis or Shoulder Adhesive Capsulitis

NCT04160091 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-01-24

Study results available
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Summary

This is a double-blind study to evaluate the efficacy and safety of FX006 in patients with glenohumeral osteoarthritis (OA) or shoulder adhesive capsulitis (AC).

Conditions

  • Osteoarthritis of the Shoulder
  • Adhesive Capsulitis

Interventions

DRUG

FX006

Single intra-articular injection

DRUG

Normal Saline

Single intra-articular injection

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • 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
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-07
Primary Completion
2020-06-15
Completion
2020-06-15
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 NCT04160091 on ClinicalTrials.gov