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Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT01746420•BioMimetic Therapeutics

View on ClinicalTrials.gov

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

Eligibility

Age

21 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject has signed the Institutional Review Board (IRB) approved Informed Consent Form specific to this study prior to enrollment
•2. Subject has a clinical diagnosis of lateral epicondylitis
•3. Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion
•4. Subject's symptoms have persisted for at least 3 months despite conservative treatment that includes one or combinations of:
•1. Physical therapy
•2. Splinting
•3. Nonsteroidal antiinflammatory drug (NSAID)
•4. Corticosteroid injection
•5. Subject is independent, ambulatory, and can comply with all post-injection evaluations and visits
•6. Subject is 21-80 years of age and considered to be skeletally mature

Exclusion Criteria

•1. Subject has undergone previous corticosteroid injection therapy to the effected elbow in less than three months prior to enrollment
•2. Subject has received previous Platelet Rich Plasma (PRP) injection to the affected elbow
•3. Subject is deemed to require a corticosteroid injection into the affected elbow during the course of the study
•4. Subject uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage \>10mg/day)
•5. Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis
•6. Subject has a positive medical history of any of the following:
•1. medial epicondylitis
•2. radial tunnel syndrome
•3. carpal tunnel syndrome
•4. septic or gouty arthritis
+13 more criteria

Locations (6)

Arizona Research Center

Phoenix, Arizona, United States

Tucson Orthopaedic Institute

Tucson, Arizona, United States

NEA Baptist Clinic

Jonesboro, Arkansas, United States

Coastal Orthopedics & Sports Medicine

Bradenton, Florida, United States

Foundation for Orthopaedic Research and Education

Tampa, Florida, United States

OrthoCarolina

Charlotte, North Carolina, United States

Key Dates

Start Date

December 12, 2012

Primary Completion Date

October 21, 2014

Completion Date

October 21, 2014

Last Updated

July 2, 2019

Enrollment

100

ACTUAL participants

Conditions

Lateral Epicondylitis

Interventions

rhPDGF-BB Injection

DRUG

Placebo

DRUG

Ultrasonographic Examination of Other Enthesitis Sites in Patients With Lateral Epicondylitis

NCT07314840

Lateral EpicondylitisLateral Elbow Tendinopathy (Tennis Elbow)

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RECRUITINGNA

Effects of Neuromuscular Reeducation Versus Friction Massage in Lateral Epicondylitis

NCT07004894

Lateral Epicondylitis

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 2, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Ultrasonographic Examination of Other Enthesitis Sites in Patients With Lateral Epicondylitis

Effects of Neuromuscular Reeducation Versus Friction Massage in Lateral Epicondylitis

Exercise Therapy and Orthoses in Lateral Elbow Tendinopathy: Comparative Effects

Hyaluronic Acid and Amino Acid Combination Versus Exercise for Chronic Lateral Epicondylitis

Neural Mobilization Exercises on Pain and Central Sensitization

Understanding Patient Preferences When Deciding on a Voluntary Musculoskeletal Test