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Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis

NCT01746420 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2019-07-02

Study results available
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Summary

The purpose of this study is to determine whether recombinant human platelet-derived growth factor (rhPDGF-BB) Injection is effective in the treatment of lateral epicondylitis (tennis elbow).

Conditions

  • Lateral Epicondylitis

Interventions

DRUG

rhPDGF-BB Injection

Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection

DRUG

Placebo

sodium acetate buffer (0 mg rhPDGF-BB)

Sponsors & Collaborators

  • BioMimetic Therapeutics

    lead INDUSTRY

Principal Investigators

  • Edward Akelman, MD · Brown University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-12-12
Primary Completion
2014-10-21
Completion
2014-10-21

Countries

  • United States

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 NCT01746420 on ClinicalTrials.gov