Phase 2
N=100
Phase II Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis
Lateral Epicondylitis
Bottom Line
View on ClinicalTrials.gov: NCT01746420 ↗Enrolled (actual)
100
Serious AEs
3.0%
Results posted
Jul 2019
Primary outcome: Primary: Elbow Pain Assessments (VAS), Treated Subjects — 76.6; 77.7; 75.9; 72 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- rhPDGF-BB Injection (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- BioMimetic Therapeutics
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Elbow Pain Assessments (VAS), Treated Subjects |
76.6; 77.7; 75.9; 72; 72.2; 67.1 | — |
| PRIMARY Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects |
43.7; 43.5; 40.1; 40; 41.3; 29.2 | — |
| PRIMARY Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects |
52.6; 56; 48.3; 52.6; 52.3; 34.7 | — |
| PRIMARY Grip Strength Test, All Treated Subjects |
42.6; 33.4; 47.6; 39.6; 39.7; 40.2 | — |
| PRIMARY Maximum Grip Strength, Treated Subjects |
60.4; 58.7; 71.8; 60.3; 61.3; 62.9 | — |
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
- 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
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:
- 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
Data sourced from ClinicalTrials.gov (NCT01746420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.