Conditions: Lateral Epicondylitis
Keywords: elbow
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief 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

Arms:
arm 1: Dose A - sodium acetate buffer (0 mg rhPDGF-BB) arm 2: Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB arm 3: Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB arm 4: Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB arm 5: Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB

Interventions: intervention 1: rhPDGF-BB Injection intervention 2: Placebo
Intervention descriptions: intervention 1: 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 intervention 2: sodium acetate buffer (0 mg rhPDGF-BB)

Protocol document: