Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2025-12-25 @ 4:29 AM
NCT ID:
NCT01746420
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
Study:
NCT01746420
Study Brief:
Protocol Section:
NCT01746420