Ignite Creation Date:
2025-12-25 @ 4:29 AM
Ignite Modification Date:
2026-01-16 @ 9:30 PM
Study NCT ID:
NCT01746420
Status:
COMPLETED
Last Update Posted:
2019-07-02
First Post:
2012-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis
Sponsor:
BioMimetic Therapeutics
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: