Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis
Condition: Lateral Epicondylitis
MeSH terms: Tennis Elbow
Intervention: rhPDGF-BB Injection; Placebo
Intervention description: Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection; sodium acetate buffer (0 mg rhPDGF-BB)
Intervention MeSH terms: Becaplermin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 100.0
Sex: All
Minimum age: 21 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: elbow

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).
    

Eligibility criteria:

        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

               5. cervical radiculopathy

               6. trauma to the affected elbow within the past 6 weeks

               7. neuromuscular or musculoskeletal deficiency, which limits the ability to perform
                  functional measurement (e.g. grip strength test)

          7. Subject currently has an acute infection at the injection site

          8. 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

          9. 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

         10. Subject has an allergy to yeast-derived products

         11. 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

         12. Subject is a prisoner, or is known or suspected to be transient

         13. Subject's condition represents a worker's compensation case

         14. Subject is currently involved in a health-related litigation procedure

         15. 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

         16. 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