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
  Purpose

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).


Condition Intervention Phase
Lateral Epicondylitis
Drug: rhPDGF-BB Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Randomized, Single Ascending Dose, Double-blinded, Placebo Controlled, Multi-center Study of the Effects of rhPDGF-BB Injection on Lateral Epicondylitis

Resource links provided by NLM:


Further study details as provided by BioMimetic Therapeutics:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Adverse events [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
    Adverse event reporting (e.g. incidence, relationship with treatment, severity)


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Control
Dose A - sodium acetate buffer (0 mg rhPDGF-BB)
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
Experimental: 0.45 mg rhPDGF-BB
Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
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
Experimental: 0.75 mg rhPDGF-BB
Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB
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
Experimental: 1.5 mg rhPDGF-BB
Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB
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
Experimental: 3.0 mg rhPDGF-BB
Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB
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

  Eligibility

Ages Eligible for Study:   21 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746420

Locations
United States, Arizona
Arizona Research Center Recruiting
Phoenix, Arizona, United States, 85023
Contact: Maria Hill    602-773-3019    mhill@azresearchcenter.com   
Principal Investigator: Joseph Gimbel, MD         
Sub-Investigator: Louise Taber, MD         
Tucson Orthopaedic Institute Recruiting
Tucson, Arizona, United States, 85712
Contact: Jelena Candito    520-784-6466    jcandito@tucsonortho.com   
Principal Investigator: Nebojsa Skrepnik, MD, PhD         
Sub-Investigator: Brian Nielsen, MD         
Sub-Investigator: Joel Goode, MD         
Sub-Investigator: Andrew Mahoney, MD         
Sponsors and Collaborators
BioMimetic Therapeutics
Investigators
Principal Investigator: Edward Akelman, MD Brown University
  More Information

No publications provided

Responsible Party: BioMimetic Therapeutics
ClinicalTrials.gov Identifier: NCT01746420     History of Changes
Other Study ID Numbers: BMTI-2010-02
Study First Received: December 7, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by BioMimetic Therapeutics:
elbow

Additional relevant MeSH terms:
Tennis Elbow
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Platelet-derived growth factor BB
Angiogenesis Inducing Agents
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014