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

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