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CompletedNCT01746420Updated Jul 2, 2019Results posted

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

A Phase 2 interventional study of rhPDGF-BB Injection and Placebo in Lateral Epicondylitis, sponsored by BioMimetic Therapeutics. Completed at 6 sites in United States. Open to participants aged 21 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-02.

Sponsored by BioMimetic Therapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
21 Years to 80 Years
Sex
All
01

Study 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).

Read the detailed description

Methodology: Randomized, single ascending dose, double-blinded, placebo controlled, multi-center study

Study Center(s): 6

Number of Subjects: 100

Diagnosis and Main Inclusion Criteria: Lateral epicondylitis; male and female subjects 21 -80 years of age

Study Drug, Dose, Regimen:

Dose A: sodium acetate buffer alone - placebo control Dose B: sodium acetate buffer + 0.45 mg rhPDGF-BB Dose C: sodium acetate buffer + 0.75 mg rhPDGF-BB Dose D: sodium acetate buffer + 1.5 mg rhPDGF-BB Dose E: sodium acetate buffer + 3.0 mg rhPDGF-BB

Duration and Route of Administration: Single administration dose by injection into the extensor carpi radialis brevis (ECRB)

Duration of Follow-up: 24 weeks (6 months) post-operative follow-up

02

Conditions studied

  • Lateral Epicondylitis

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Keywords

  • elbow
03

In context

Tennis Elbow

284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.

This study's enrollment of 100 is above the median of 50 across 253 interventional studies indexed under Tennis Elbow.

Browse Tennis Elbow studies →

Lead sponsor

BioMimetic Therapeutics is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
100 participants (actual)

Study arms

  • Placebo comparator
    Placebo Control

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

    Drug: Placebo

  • Experimental
    0.45 mg rhPDGF-BB

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

    Drug: rhPDGF-BB Injection

  • Experimental
    0.75 mg rhPDGF-BB

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

    Drug: rhPDGF-BB Injection

  • Experimental
    1.5 mg rhPDGF-BB

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

    Drug: rhPDGF-BB Injection

  • Experimental
    3.0 mg rhPDGF-BB

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

    Drug: rhPDGF-BB Injection

Interventions

  • DrugrhPDGF-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

  • DrugPlacebo

    sodium acetate buffer (0 mg rhPDGF-BB)

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline, 2, 4, 8, 12, and 24 weeks

  2. 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.

    Time frame: Baseline, 4, 8, 12, and 24 weeks

  3. 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

    Time frame: Baseline, 4, 8, 12, and 24 weeks

  4. 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.

    Time frame: Baseline, 4, 8, 12, and 24 weeks

  5. 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.

    Time frame: Baseline, 4, 8, 12, and 24 weeks

07

Results

Posted Jul 2, 2019
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.

Participant flow

Participant flow — Overall Study
MilestonePlacebo Control0.45 mg rhPDGF-BB0.75 mg rhPDGF-BB1.5 mg rhPDGF-BB3.0 mg rhPDGF-BB
Started2020202020
Completed1718172020
Not completed32300

Outcome measures

PrimaryElbow 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).

Time frame:
Baseline, 2, 4, 8, 12, and 24 weeks
Reported as:
Mean · score on a scale
Elbow Pain Assessments (VAS), Treated Subjects
score on a scalePlacebo Control0.45 mg rhPDGF-BB0.75 mg rhPDGF-BB1.5 mg rhPDGF-BB3.0 mg rhPDGF-BB
Baseline76.6 ± 14.477.7 ± 9.275.9 ± 16.972 ± 19.972.2 ± 20.6
Week 267.1 ± 1573.2 ± 14.678.5 ± 18.459.7 ± 22.770 ± 26.6
Week 449.9 ± 1849.8 ± 21.155.5 ± 2740.2 ± 24.152.5 ± 27.3
Week 835.9 ± 23.439.7 ± 19.547.2 ± 20.833 ± 27.239.1 ± 28.8
Week 1228.7 ± 20.231.2 ± 21.636.7 ± 25.329.8 ± 29.740.4 ± 29
Week 2416.9 ± 2123.1 ± 25.628.5 ± 2623.8 ± 28.232.1 ± 31.4
PrimaryDisabilities 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.

Time frame:
Baseline, 4, 8, 12, and 24 weeks
Reported as:
Mean · score on a scale
Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects
score on a scalePlacebo Control0.45 mg rhPDGF-BB0.75 mg rhPDGF-BB1.5 mg rhPDGF-BB3.0 mg rhPDGF-BB
Baseline43.7 ± 13.943.5 ± 13.540.1 ± 19.840 ± 15.341.3 ± 18.5
Week 429.2 ± 12.530.9 ± 12.834.1 ± 18.327.8 ± 20.238.3 ± 22.9
Week 821.8 ± 11.523 ± 14.224.7 ± 14.919.7 ± 16.425.1 ± 22.5
Week 1212.6 ± 8.616.7 ± 13.219.8 ± 15.316.1 ± 15.924.5 ± 23.7
Week 247.2 ± 9.611.4 ± 9.914.5 ± 17.313.8 ± 15.619.6 ± 24.3
PrimaryTotal 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

Time frame:
Baseline, 4, 8, 12, and 24 weeks
Reported as:
Mean · score on a scale
Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects
score on a scalePlacebo Control0.45 mg rhPDGF-BB0.75 mg rhPDGF-BB1.5 mg rhPDGF-BB3.0 mg rhPDGF-BB
Baseline52.6 ± 17.956 ± 14.348.3 ± 16.352.6 ± 20.752.3 ± 22.9
Week 434.7 ± 14.539.2 ± 15.339.3 ± 21.732.2 ± 23.943.4 ± 24.3
Week 825.2 ± 15.226.9 ± 17.428.9 ± 15.125.4 ± 2128.6 ± 24.9
Week 1213.5 ± 818.2 ± 16.422.3 ± 16.420.1 ± 22.726.8 ± 24.8
Week 247.8 ± 1012.1 ± 12.416.2 ± 17.916.8 ± 19.322.3 ± 27.3
PrimaryGrip 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.

Time frame:
Baseline, 4, 8, 12, and 24 weeks
Reported as:
Mean · lbs.
Grip Strength Test, All Treated Subjects
lbs.Placebo Control0.45 mg rhPDGF-BB0.75 mg rhPDGF-BB1.5 mg rhPDGF-BB3.0 mg rhPDGF-BB
Baseline42.6 ± 30.133.4 ± 24.147.6 ± 29.439.6 ± 28.939.7 ± 23.2
Week 440.2 ± 25.644.5 ± 3248.3 ± 3352 ± 30.241.9 ± 26.3
Week 853.5 ± 27.850.6 ± 36.364.6 ± 3553.3 ± 2954.8 ± 26.4
Week 1258.2 ± 28.161 ± 37.767.5 ± 38.361.1 ± 32.145.1 ± 25.3
Week 2466.4 ± 26.469.1 ± 37.579.9 ± 33.469.9 ± 29.162.9 ± 25.7
PrimaryMaximum 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.

Time frame:
Baseline, 4, 8, 12, and 24 weeks
Reported as:
Mean · lbs.
Maximum Grip Strength, Treated Subjects
lbs.Placebo Control0.45 mg rhPDGF-BB0.75 mg rhPDGF-BB1.5 mg rhPDGF-BB3.0 mg rhPDGF-BB
Baseline60.4 ± 3558.7 ± 33.171.8 ± 38.960.3 ± 31.261.3 ± 29.7
Week 462.9 ± 26.263.5 ± 33.164.2 ± 37.268.9 ± 35.562 ± 33
Week 873.3 ± 29.366.4 ± 31.372.9 ± 3771.6 ± 3066.9 ± 31.5
Week 1278.9 ± 29.968.6 ± 31.281.8 ± 39.774.5 ± 32.865.1 ± 30
Week 2482.5 ± 32.771 ± 32.580.7 ± 33.777.8 ± 2776.4 ± 30.9

Adverse events

Collected over Patients were assessed through study completion scheduled at 24 weeks following surgery.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo Control—0/20 (0%)15/20 (75%)
0.45 mg rhPDGF-BB—0/20 (0%)20/20 (100%)
0.75 mg rhPDGF-BB—2/20 (10%)18/20 (90%)
1.5 mg rhPDGF-BB—0/20 (0%)16/20 (80%)
3.0 mg rhPDGF-BB—1/20 (5%)18/20 (90%)
Most frequent serious events
Most frequent serious events
EventPlacebo Control0.45 mg rhPDGF-BB0.75 mg rhPDGF-BB1.5 mg rhPDGF-BB3.0 mg rhPDGF-BB
Injection site calcificationGeneral disorders0/200/201/200/200/20
Anaphylactic reactionImmune system disorders0/200/201/200/200/20
Road traffic accidentInjury, poisoning and procedural complications0/200/200/200/201/20
Most frequent other events
Showing 10 of 106
Most frequent other events
EventPlacebo Control0.45 mg rhPDGF-BB0.75 mg rhPDGF-BB1.5 mg rhPDGF-BB3.0 mg rhPDGF-BB
Injection site painGeneral disorders3/208/205/206/2012/20
ArthralgiaMusculoskeletal and connective tissue disorders4/206/209/204/205/20
Procedural painInjury, poisoning and procedural complications3/207/204/200/200/20
Injection site swellingGeneral disorders0/206/201/203/204/20
Joint swellingMusculoskeletal and connective tissue disorders1/202/203/202/206/20
Joint range of motion decreasedMusculoskeletal and connective tissue disorders0/204/200/202/201/20
Joint stiffnessMusculoskeletal and connective tissue disorders0/204/204/202/203/20
Joint warmthMusculoskeletal and connective tissue disorders0/200/204/202/204/20
Pain in extremityMusculoskeletal and connective tissue disorders2/203/202/202/204/20
ParaesthesiaNervous system disorders2/202/200/200/204/20

Baseline characteristics

Age, Customized
Age, Customized(years)Placebo Control0.45 mg rhPDGF-BB0.75 mg rhPDGF-BB1.5 mg rhPDGF-BB3.0 mg rhPDGF-BBTotal
Age44.2 ± 7.149 ± 6.946 ± 747.4 ± 12.449 ± 8.347.1 ± 8.6
Sex: Female, Male
Sex: Female, Male(Participants)Placebo Control0.45 mg rhPDGF-BB0.75 mg rhPDGF-BB1.5 mg rhPDGF-BB3.0 mg rhPDGF-BBTotal
Female1212810951
Male8812101149
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Placebo Control0.45 mg rhPDGF-BB0.75 mg rhPDGF-BB1.5 mg rhPDGF-BB3.0 mg rhPDGF-BBTotal
American Indian or Alaska Native000011
Asian010113
Native Hawaiian or Other Pacific Islander000000
Black or African American100135
White181920171589
More than one race100102
Unknown or Not Reported000000
08

Study locations

6 sites
  • Arizona Research Center
    Phoenix, Arizona 85023, United States
  • Tucson Orthopaedic Institute
    Tucson, Arizona 85712, United States
  • NEA Baptist Clinic
    Jonesboro, Arkansas 72401, United States
  • Coastal Orthopedics & Sports Medicine
    Bradenton, Florida 34209, United States
  • Foundation for Orthopaedic Research and Education
    Tampa, Florida 33637, United States
  • OrthoCarolina
    Charlotte, North Carolina 28207, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01746420
Lead sponsor
BioMimetic Therapeutics
Responsible party
Sponsor
First posted
Dec 11, 2012
Start date
Dec 12, 2012
Primary completion
Oct 21, 2014
Completion
Oct 21, 2014
Results posted
Jul 2, 2019
Last update
Jul 2, 2019

Study contacts

Edward Akelman, MD
principal investigator · Brown University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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