NCT01746420

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: BioMimetic Therapeutics · Industry
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed 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

Conditions

• Lateral Epicondylitis

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2012-12-12
• Primary completion: 2014-10-21
• Completion: 2014-10-21
• First posted: 2012-12-11
• Last updated: 2019-07-02
• Results posted: 2019-07-02

Locations

6 sites across 1 country: United States