Lateral EpicondylitisPhase 2NCT01746420

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

A Phase 2 study testing rhPDGF-BB Injection in people with Lateral Epicondylitis, run by BioMimetic Therapeutics at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 more about this study

Who is it for?: Ages 21 to 80 years
Conditions the study is for: Lateral Epicondylitis
What is being tested?: rhPDGF-BB Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 6 sitesUnited States
Study dates: 12 Dec 2012to 21 Oct 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 10Show fewer

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

Who cannot join

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:

Show all 23Show fewer

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

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

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

Other trials in United States

About this study

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

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

Conditions: Lateral Epicondylitis
Being tested: rhPDGF-BB Injection, Placebo
Keywords: elbow
Medical subject headings: Tennis Elbow

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

rhPDGF-BB InjectionDrug
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
PlaceboDrug
sodium acetate buffer (0 mg rhPDGF-BB)

Study groups in NCT01746420
Study group	Role	What they receive
Placebo Control	Placebo comparator	Dose A - sodium acetate buffer (0 mg rhPDGF-BB) Receives: Drug: Placebo
0.45 mg rhPDGF-BB	Experimental	Dose B - sodium acetate buffer + 0.45 mg rhPDGF-BB Receives: Drug: rhPDGF-BB Injection
0.75 mg rhPDGF-BB	Experimental	Dose C - sodium acetate buffer + 0.75 mg rhPDGF-BB Receives: Drug: rhPDGF-BB Injection
1.5 mg rhPDGF-BB	Experimental	Dose D - sodium acetate buffer + 1.5 mg rhPDGF-BB Receives: Drug: rhPDGF-BB Injection
3.0 mg rhPDGF-BB	Experimental	Dose E - sodium acetate buffer + 3.0 mg rhPDGF-BB Receives: Drug: rhPDGF-BB Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Baseline, 4, 8, 12, and 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Dec 201221 Oct 2014

First posted11 Dec 2012 (estimated)
Study start12 Dec 2012
Primary completion21 Oct 2014
Study completion21 Oct 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01746420
Sponsor's protocol ID: BMTI-2010-02
Status last verified: Jun 2019
First submitted: 7 Dec 2012
Last updated: 2 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
Lateral Epicondylitis, Medial Epicondylitis
Recruiting
A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
Not yet recruiting
Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis

All Lateral Epicondylitis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01746420
Acronym / sponsor ID: BMTI-2010-02
Conditions: Lateral Epicondylitis
Keywords: elbow
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: BioMimetic TherapeuticsIndustry (pharma, biotech, devices)
Study start: 12 Dec 2012 (actual)
Primary completion: 21 Oct 2014 (actual)
Study completion: 21 Oct 2014 (actual)
First posted: 11 Dec 2012 (estimated)
Results: Posted 2 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

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:

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Placebo Control	Placebo comparator	Drug: PlaceboDose A - sodium acetate buffer (0 mg rhPDGF-BB)
0.45 mg rhPDGF-BB	Experimental	Drug: rhPDGF-BB InjectionDose B - sodium acetate buffer + 0.45 mg rhPDGF-BB
0.75 mg rhPDGF-BB	Experimental	Drug: rhPDGF-BB InjectionDose C - sodium acetate buffer + 0.75 mg rhPDGF-BB
1.5 mg rhPDGF-BB	Experimental	Drug: rhPDGF-BB InjectionDose D - sodium acetate buffer + 1.5 mg rhPDGF-BB
3.0 mg rhPDGF-BB	Experimental	Drug: rhPDGF-BB InjectionDose E - sodium acetate buffer + 3.0 mg rhPDGF-BB

Who may qualify

Ages: 21 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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:
Subject is independent, ambulatory, and can comply with all post-injection evaluations and visits

Key exclusion criteria (23 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
rhPDGF-BB InjectionComparison 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	Drug	0.45 mg rhPDGF-BB, 0.75 mg rhPDGF-BB, 1.5 mg rhPDGF-BB, 3.0 mg rhPDGF-BB
Placebosodium acetate buffer (0 mg rhPDGF-BB)	Drug	Placebo Control

Primary outcome

Elbow Pain Assessments (VAS), Treated Subjects
Time frame: Baseline, 2, 4, 8, 12, and 24 weeks
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).
Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects
Time frame: Baseline, 4, 8, 12, and 24 weeks
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.
Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects
Time frame: Baseline, 4, 8, 12, and 24 weeks
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
Grip Strength Test, All Treated Subjects
Time frame: Baseline, 4, 8, 12, and 24 weeks
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.
Maximum Grip Strength, Treated Subjects
Time frame: Baseline, 4, 8, 12, and 24 weeks
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.

Results and safety

Results posted to the registry on 2 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo Control	20	17
0.45 mg rhPDGF-BB	20	18
0.75 mg rhPDGF-BB	20	17
1.5 mg rhPDGF-BB	20	20
3.0 mg rhPDGF-BB	20	20

Primary outcome: Elbow Pain Assessments (VAS), Treated Subjects

Time frame: Baseline, 2, 4, 8, 12, and 24 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo Control n = 20	0.45 mg rhPDGF-BB n = 20	0.75 mg rhPDGF-BB n = 20	1.5 mg rhPDGF-BB n = 20	3.0 mg rhPDGF-BB n = 20
Baseline	76.6 (14.4)	77.7 (9.2)	75.9 (16.9)	72 (19.9)	72.2 (20.6)
Week 2	67.1 (15)	73.2 (14.6)	78.5 (18.4)	59.7 (22.7)	70 (26.6)
Week 4	49.9 (18)	49.8 (21.1)	55.5 (27)	40.2 (24.1)	52.5 (27.3)
Week 8	35.9 (23.4)	39.7 (19.5)	47.2 (20.8)	33 (27.2)	39.1 (28.8)
Week 12	28.7 (20.2)	31.2 (21.6)	36.7 (25.3)	29.8 (29.7)	40.4 (29)
Week 24	16.9 (21)	23.1 (25.6)	28.5 (26)	23.8 (28.2)	32.1 (31.4)

Population analysed: Analysis conducted on patients at Baseline, 2, 4, 8, 12, and 24 weeks time points.

Primary outcome: Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects

Time frame: Baseline, 4, 8, 12, and 24 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo Control n = 20	0.45 mg rhPDGF-BB n = 20	0.75 mg rhPDGF-BB n = 20	1.5 mg rhPDGF-BB n = 20	3.0 mg rhPDGF-BB n = 20
Baseline	43.7 (13.9)	43.5 (13.5)	40.1 (19.8)	40 (15.3)	41.3 (18.5)
Week 4	29.2 (12.5)	30.9 (12.8)	34.1 (18.3)	27.8 (20.2)	38.3 (22.9)
Week 8	21.8 (11.5)	23 (14.2)	24.7 (14.9)	19.7 (16.4)	25.1 (22.5)
Week 12	12.6 (8.6)	16.7 (13.2)	19.8 (15.3)	16.1 (15.9)	24.5 (23.7)
Week 24	7.2 (9.6)	11.4 (9.9)	14.5 (17.3)	13.8 (15.6)	19.6 (24.3)

Population analysed: Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.

Primary outcome: Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects

Time frame: Baseline, 4, 8, 12, and 24 weeks. Mean (Standard Deviation). Unit: score on a scale

Measure	Placebo Control n = 20	0.45 mg rhPDGF-BB n = 20	0.75 mg rhPDGF-BB n = 20	1.5 mg rhPDGF-BB n = 20	3.0 mg rhPDGF-BB n = 20
Baseline	52.6 (17.9)	56 (14.3)	48.3 (16.3)	52.6 (20.7)	52.3 (22.9)
Week 4	34.7 (14.5)	39.2 (15.3)	39.3 (21.7)	32.2 (23.9)	43.4 (24.3)
Week 8	25.2 (15.2)	26.9 (17.4)	28.9 (15.1)	25.4 (21)	28.6 (24.9)
Week 12	13.5 (8)	18.2 (16.4)	22.3 (16.4)	20.1 (22.7)	26.8 (24.8)
Week 24	7.8 (10)	12.1 (12.4)	16.2 (17.9)	16.8 (19.3)	22.3 (27.3)

Population analysed: Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.

Primary outcome: Grip Strength Test, All Treated Subjects

Time frame: Baseline, 4, 8, 12, and 24 weeks. Mean (Standard Deviation). Unit: lbs.

Measure	Placebo Control n = 20	0.45 mg rhPDGF-BB n = 20	0.75 mg rhPDGF-BB n = 20	1.5 mg rhPDGF-BB n = 20	3.0 mg rhPDGF-BB n = 20
Baseline	42.6 (30.1)	33.4 (24.1)	47.6 (29.4)	39.6 (28.9)	39.7 (23.2)
Week 4	40.2 (25.6)	44.5 (32)	48.3 (33)	52 (30.2)	41.9 (26.3)
Week 8	53.5 (27.8)	50.6 (36.3)	64.6 (35)	53.3 (29)	54.8 (26.4)
Week 12	58.2 (28.1)	61 (37.7)	67.5 (38.3)	61.1 (32.1)	45.1 (25.3)
Week 24	66.4 (26.4)	69.1 (37.5)	79.9 (33.4)	69.9 (29.1)	62.9 (25.7)

Population analysed: Analysis conducted on patients at Baseline, 4, 8, 12, and 24 weeks time points.

Adverse events

Time frame: Patients were assessed through study completion scheduled at 24 weeks following surgery.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Control	0 of 20 (0%)	15 of 20 (75%)	Not reported
0.45 mg rhPDGF-BB	0 of 20 (0%)	20 of 20 (100%)	Not reported
0.75 mg rhPDGF-BB	2 of 20 (10%)	18 of 20 (90%)	Not reported
1.5 mg rhPDGF-BB	0 of 20 (0%)	16 of 20 (80%)	Not reported
3.0 mg rhPDGF-BB	1 of 20 (5%)	18 of 20 (90%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lateral Epicondylitis

Not yet recruitingObservational study
Investigation of Obsessive-Compulsive Disorder in Patients With Elbow Epicondylitis
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A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Edward Akelman, MD principal investigator

Brown University

6 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing rhPDGF-BB Injection in people with Lateral Epicondylitis, run by BioMimetic Therapeutics at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Elbow Pain Assessments (VAS), Treated Subjects (time frame: Baseline, 2, 4, 8, 12, and 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01746420.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2019.