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

NCT01746420 | Completed Phase 2 Results DMC

• 1 other identifier: BMTI-2010-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 6

Brief 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).

Conditions

Lateral Epicondylitis

Keywords

elbow

Outcome Measures

Primary Outcomes (5)

• Elbow Pain Assessments (VAS), Treated Subjects

  Subjects were asked to report current pain level at the fusion site on a 100 mm Visual Analog Scale (with 0 being no pain and 100 being worst pain imaginable).

  Baseline, 2, 4, 8, 12, and 24 weeks

• Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects

  The disabilities of the arm, shoulder and hand (DASH) questionnaire is a self-administered region-specific outcome instrument developed as a measure of self-rated upper-extremity disability and symptoms. The DASH consists mainly of a 30-item disability/symptom scale, scored 0 (no disability) to 100.

  Baseline, 4, 8, 12, and 24 weeks

• Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects

  The Pain and disability measured by the Patient Rated Tennis Elbow Evaluation (PRTEE) is a 15-item questionnaire designed to measure forearm pain and disability in patients with lateral epicondylitis (also known as "tennis elbow"). The PRTEE allows patients to rate their levels of tennis elbow pain and disability from 0 to 10, and consists of 2 subscales: 1. PAIN subscale (0 = no pain, 10 = worst imaginable) -Pain - 5 items 2. FUNCTION subscale (0 = no difficulty, 10 = unable to do) * Specific activities - 6 items * Usual activities - 4 items In addition to the individual subscale scores, a total score can be computed on a scale of 100 (0 = no disability), where pain and functional problems are weighted equally

  Baseline, 4, 8, 12, and 24 weeks

• Grip Strength Test, All Treated Subjects

  Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis.

  Baseline, 4, 8, 12, and 24 weeks

• Maximum Grip Strength, Treated Subjects

  A higher grip strength score indicates an improvement. A positive change from baseline indicates an improvement. Grip strength testing will be performed to evaluate changes in the strength and sincerity of effort as a result of treatment for lateral epicondylitis. Testing will be performed to assess the pain-free grip strength (performing the test until discomfort is felt) and maximum grip strength (performing the test to the maximum of their ability). The test will be performed while the patient is standing with the elbow in full extension, as this position has been used to assess grip strength in patients with lateral epicondylitis. A Jamar Plus+ Digital Hand Dynamometer with the grip in the second position will be used because the second position has been assumed to be the most reliable and consistent position. Patients will be asked to perform three repetitions of each test (pain-free and maximum) at each study interval and the mean score will be calculated and used for analysis.

  Baseline, 4, 8, 12, and 24 weeks

Study Arms (5)

Placebo Control

PLACEBO COMPARATOR

Dose A - sodium acetate buffer (0 mg rhPDGF-BB)

Drug: Placebo

0.45 mg rhPDGF-BB

EXPERIMENTAL

Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB

Drug: rhPDGF-BB Injection

0.75 mg rhPDGF-BB

EXPERIMENTAL

Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB

Drug: rhPDGF-BB Injection

1.5 mg rhPDGF-BB

EXPERIMENTAL

Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB

Drug: rhPDGF-BB Injection

3.0 mg rhPDGF-BB

EXPERIMENTAL

Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB

Drug: rhPDGF-BB Injection

Interventions

rhPDGF-BB Injection DRUG

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

0.45 mg rhPDGF-BB; 0.75 mg rhPDGF-BB; 1.5 mg rhPDGF-BB; 3.0 mg rhPDGF-BB

Placebo DRUG

sodium acetate buffer (0 mg rhPDGF-BB)

Placebo Control

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• BioMimetic Therapeutics: lead

Study Sites (6)

Arizona Research Center

Phoenix, Arizona, 85023, United States

Location

Tucson Orthopaedic Institute

Tucson, Arizona, 85712, United States

Location

NEA Baptist Clinic

Jonesboro, Arkansas, 72401, United States

Location

Coastal Orthopedics & Sports Medicine

Bradenton, Florida, 34209, United States

Location

Foundation for Orthopaedic Research and Education

Tampa, Florida, 33637, United States

Location

OrthoCarolina

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Tennis Elbow

Interventions

Becaplermin

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Proto-Oncogene Proteins c-sis; Platelet-Derived Growth Factor; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; DNA-Binding Proteins; Proteins; Biological Factors

Limitations and Caveats

While this preliminary study suggests similar safety profiles for PDGF and placebo, future studies with larger sample sizes, possibly different concentrations, and tighter inclusion criteria are needed to definitely assess the effectiveness of PDGF.

Results Point of Contact

• Title: Justin Moss
• Organization: Wright Medical

justin.moss@wright.com

615-236-4984

Study Officials

• Edward Akelman, MD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 11, 2012
• Study Start: December 12, 2012
• Primary Completion: October 21, 2014
• Study Completion: October 21, 2014
• Last Updated: July 2, 2019
• Results First Posted: July 2, 2019

Record last verified: 2019-06

Locations

US (6)