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

Lateral Epicondylitis Clinical Trial

Official title:
A Phase II Randomized, Single Ascending Dose, Double-blinded, Placebo Controlled, Multi-center Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis

Clinical Trial 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).

Clinical Trial Description

Methodology: Randomized, single ascending dose, double-blinded, placebo controlled, multi-center study

Study Center(s): 6

Number of Subjects: 100

Diagnosis and Main Inclusion Criteria: Lateral epicondylitis; male and female subjects 21 -80 years of age

Study Drug, Dose, Regimen:

Dose A: sodium acetate buffer alone - placebo control Dose B: sodium acetate buffer + 0.45 mg rhPDGF-BB Dose C: sodium acetate buffer + 0.75 mg rhPDGF-BB Dose D: sodium acetate buffer + 1.5 mg rhPDGF-BB Dose E: sodium acetate buffer + 3.0 mg rhPDGF-BB

Duration and Route of Administration: Single administration dose by injection into the extensor carpi radialis brevis (ECRB)

Duration of Follow-up: 24 weeks (6 months) post-operative follow-up ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01746420
Study type Interventional
Source BioMimetic Therapeutics
Contact
Status Completed
Phase Phase 2
Start date December 12, 2012
Completion date October 21, 2014
View Details
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