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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by BioMimetic Therapeutics
Sponsor:
Information provided by (Responsible Party):
BioMimetic Therapeutics
ClinicalTrials.gov Identifier:
NCT01746420
First received: December 7, 2012
Last updated: December 10, 2012
Last verified: December 2012

December 7, 2012
December 10, 2012
December 2012
March 2014   (final data collection date for primary outcome measure)
  • Elbow pain [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Elbow pain as measured by the Visual Analogue Scale
  • Disability and symptoms [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Disability and symptoms measured by the Disabilities of the Arm, Shoulder, and Hand (DASH) Score
  • Pain and disability [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Pain and disability measured by the Patient Rated Tennis Elbow Evaluation (PRTEE)
  • Sincerity of effort [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Sincerity of effort measured by Grip Strength testing
Same as current
Complete list of historical versions of study NCT01746420 on ClinicalTrials.gov Archive Site
Adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Adverse event reporting (e.g. incidence, relationship with treatment, severity)
Same as current
Not Provided
Not Provided
 
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Lateral Epicondylitis
Drug: rhPDGF-BB Injection
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
  • Placebo Comparator: Placebo Control
    Dose A - sodium acetate buffer (0 mg rhPDGF-BB)
    Intervention: Drug: rhPDGF-BB Injection
  • Experimental: 0.45 mg rhPDGF-BB
    Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
    Intervention: Drug: rhPDGF-BB Injection
  • Experimental: 0.75 mg rhPDGF-BB
    Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB
    Intervention: Drug: rhPDGF-BB Injection
  • Experimental: 1.5 mg rhPDGF-BB
    Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB
    Intervention: Drug: rhPDGF-BB Injection
  • Experimental: 3.0 mg rhPDGF-BB
    Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB
    Intervention: Drug: rhPDGF-BB Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
21 Years to 80 Years
No
United States
 
NCT01746420
BMTI-2010-02
Yes
BioMimetic Therapeutics
BioMimetic Therapeutics
Not Provided
Principal Investigator: Edward Akelman, MD Brown University
BioMimetic Therapeutics
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP