Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis
Completed · Phase 2 · Has a placebo group
Conditions studied: Lateral Epicondylitis
In brief
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).
Key facts
- Study ID
- NCT01746420
- Run by
- BioMimetic Therapeutics
- People needed
- 100
- Starts
- 2012-12-12
- Expected to finish
- 2014-10-21
- Last updated by the study team
- 2019-07-02
Who can join
Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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:
- Physical therapy
- Splinting
- Nonsteroidal antiinflammatory drug (NSAID)
- Corticosteroid injection
- 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
You may not qualify if…
- 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:
- medial epicondylitis
- radial tunnel syndrome
- carpal tunnel syndrome
- septic or gouty arthritis
- cervical radiculopathy
- trauma to the affected elbow within the past 6 weeks
- neuromuscular or musculoskeletal deficiency, which limits the ability to perform functional measurement (e.g. grip strength test)
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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