Status and phase
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About
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).
Full 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
Enrollment
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Volunteers
Inclusion criteria
Subject has signed the Institutional Review Board (IRB) approved Informed Consent Form specific to this study prior to enrollment
Subject has a clinical diagnosis of lateral epicondylitis
Subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion
Subject's symptoms have persisted for at least 3 months despite conservative treatment that includes one or combinations of:
Subject is independent, ambulatory, and can comply with all post-injection evaluations and visits
Subject is 21-80 years of age and considered to be skeletally mature
Exclusion criteria
Subject has undergone previous corticosteroid injection therapy to the effected elbow in less than three months prior to enrollment
Subject has received previous Platelet Rich Plasma (PRP) injection to the affected elbow
Subject is deemed to require a corticosteroid injection into the affected elbow during the course of the study
Subject uses chronic medications known to affect the skeleton (e.g. glucocorticoid usage >10mg/day)
Subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis
Subject has a positive medical history of any of the following:
Subject currently has an acute infection at the injection site
Subject has tested positive or been treated for a malignancy in the past or is suspected of having a malignancy or are currently undergoing radio- or chemotherapy treatment for a malignancy anywhere in the body, whether adjacent to or distant from the proposed rhPDGF-BB Injection treatment site
Subject is physically or mentally compromised (e.g. currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.) to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant
Subject has an allergy to yeast-derived products
Subject has received an investigational therapy or approved therapy for investigational use within 30 days of injection procedure or during the follow-up phase of this study
Subject is a prisoner, or is known or suspected to be transient
Subject's condition represents a worker's compensation case
Subject is currently involved in a health-related litigation procedure
Subject has documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within the 12 months prior to screening for study entry
Subject is pregnant, or able to become pregnant but not practicing a medically-accepted form of birth control, and/or intending to become pregnant during this study period
Primary purpose
Allocation
Interventional model
Masking
100 participants in 5 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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