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NCT01746420 · ClinicalTrials.gov registry record · Phase 2
Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis
A Phase 2 study of Lateral Epicondylitis, sponsored by BioMimetic Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 100
- Enrollment target
- 6
- Study locations
NCT01746420: Completed Phase 2 study of Lateral Epicondylitis, sponsored by BioMimetic Therapeutics.
NCT01746420 is a Phase 2 study of Lateral Epicondylitis that has completed, run by BioMimetic Therapeutics. The registered enrollment target is 100 participants, below the 113-participant average among 7 other Lateral Epicondylitis trials with a reported enrollment target (12% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01746420, a Phase 2 study of Lateral Epicondylitis, has completed, sponsored by BioMimetic Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 100 participants
- Enrollment target
- 6
- Study locations
Study 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).
Primary Outcome
Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).
Conditions Studied
Interventions
- DRUG Placebo
- DRUG rhPDGF-BB Injection
Study Locations (6)
Arizona
- Arizona Research Center - Phoenix
- Tucson Orthopaedic Institute - Tucson
Florida
- Coastal Orthopedics & Sports Medicine - Bradenton
- Foundation for Orthopaedic Research and Education - Tampa
Arkansas
- NEA Baptist Clinic - Jonesboro
North Carolina
- OrthoCarolina - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2012-12-12 |
| Est. Completion | 2014-10-21 |
| Phase | Phase 2 |
What the finished NCT01746420 record still lists
NCT01746420 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 113-participant average among 7 other Lateral Epicondylitis trials with a reported enrollment target (12% lower).
The record links to 1 condition, with Lateral Epicondylitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01746420 lists 6 locations in 4 states (Arizona, Florida, Arkansas).
Frequently Asked Questions
What is clinical trial NCT01746420 about?
NCT01746420 is a clinical study titled "Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis". 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).
What is the current status of trial NCT01746420?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2012-12-12. Estimated completion is 2014-10-21.
What conditions does trial NCT01746420 study?
This clinical trial studies the following conditions: Lateral Epicondylitis.
What interventions are being tested in trial NCT01746420?
The interventions under investigation include: Placebo (DRUG), rhPDGF-BB Injection (DRUG).
Who is sponsoring clinical trial NCT01746420?
This trial is sponsored by BioMimetic Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01746420 being conducted?
This trial has 6 study locations across Arizona, Arkansas, Florida, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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