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NCT01746420

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

Completed Phase 2 Results posted Last updated 2 July 2019
What this trial tests

Phase 2 trial testing rhPDGF-BB Injection in Lateral Epicondylitis in 100 participants. Completed in 21 October 2014.

Timeline
12 December 2012
Primary endpoint
21 October 2014
21 October 2014

Quick facts

Lead sponsorBioMimetic Therapeutics
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment100
Start date12 December 2012
Primary completion21 October 2014
Estimated completion21 October 2014
Sites6 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

BioMimetic Therapeutics

Who can join

Adults 21 to 80, any sex, with Lateral Epicondylitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Elbow Pain Assessments (VAS), Treated Subjects Primary · 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).

Baseline
GroupValue95% CI
Placebo Control76.6± 14.4
0.45 mg rhPDGF-BB77.7± 9.2
0.75 mg rhPDGF-BB75.9± 16.9
1.5 mg rhPDGF-BB72± 19.9
3.0 mg rhPDGF-BB72.2± 20.6
Week 2
GroupValue95% CI
Placebo Control67.1± 15
0.45 mg rhPDGF-BB73.2± 14.6
0.75 mg rhPDGF-BB78.5± 18.4
1.5 mg rhPDGF-BB59.7± 22.7
3.0 mg rhPDGF-BB70± 26.6
Week 4
GroupValue95% CI
Placebo Control49.9± 18
0.45 mg rhPDGF-BB49.8± 21.1
0.75 mg rhPDGF-BB55.5± 27
1.5 mg rhPDGF-BB40.2± 24.1
3.0 mg rhPDGF-BB52.5± 27.3
Week 8
GroupValue95% CI
Placebo Control35.9± 23.4
0.45 mg rhPDGF-BB39.7± 19.5
0.75 mg rhPDGF-BB47.2± 20.8
1.5 mg rhPDGF-BB33± 27.2
3.0 mg rhPDGF-BB39.1± 28.8
Week 12
GroupValue95% CI
Placebo Control28.7± 20.2
0.45 mg rhPDGF-BB31.2± 21.6
0.75 mg rhPDGF-BB36.7± 25.3
1.5 mg rhPDGF-BB29.8± 29.7
3.0 mg rhPDGF-BB40.4± 29
Week 24
GroupValue95% CI
Placebo Control16.9± 21
0.45 mg rhPDGF-BB23.1± 25.6
0.75 mg rhPDGF-BB28.5± 26
1.5 mg rhPDGF-BB23.8± 28.2
3.0 mg rhPDGF-BB32.1± 31.4
Disabilities of the Arm, Shoulder and Hand (DASH), Treated Subjects Primary · 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.

Baseline
GroupValue95% CI
Placebo Control43.7± 13.9
0.45 mg rhPDGF-BB43.5± 13.5
0.75 mg rhPDGF-BB40.1± 19.8
1.5 mg rhPDGF-BB40± 15.3
3.0 mg rhPDGF-BB41.3± 18.5
Week 4
GroupValue95% CI
Placebo Control29.2± 12.5
0.45 mg rhPDGF-BB30.9± 12.8
0.75 mg rhPDGF-BB34.1± 18.3
1.5 mg rhPDGF-BB27.8± 20.2
3.0 mg rhPDGF-BB38.3± 22.9
Week 8
GroupValue95% CI
Placebo Control21.8± 11.5
0.45 mg rhPDGF-BB23± 14.2
0.75 mg rhPDGF-BB24.7± 14.9
1.5 mg rhPDGF-BB19.7± 16.4
3.0 mg rhPDGF-BB25.1± 22.5
Week 12
GroupValue95% CI
Placebo Control12.6± 8.6
0.45 mg rhPDGF-BB16.7± 13.2
0.75 mg rhPDGF-BB19.8± 15.3
1.5 mg rhPDGF-BB16.1± 15.9
3.0 mg rhPDGF-BB24.5± 23.7
Week 24
GroupValue95% CI
Placebo Control7.2± 9.6
0.45 mg rhPDGF-BB11.4± 9.9
0.75 mg rhPDGF-BB14.5± 17.3
1.5 mg rhPDGF-BB13.8± 15.6
3.0 mg rhPDGF-BB19.6± 24.3
Total Score Patient Rated Tennis Elbow Evaluation (PRTEE), All Treated Subjects Primary · 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

Baseline
GroupValue95% CI
Placebo Control52.6± 17.9
0.45 mg rhPDGF-BB56± 14.3
0.75 mg rhPDGF-BB48.3± 16.3
1.5 mg rhPDGF-BB52.6± 20.7
3.0 mg rhPDGF-BB52.3± 22.9
Week 4
GroupValue95% CI
Placebo Control34.7± 14.5
0.45 mg rhPDGF-BB39.2± 15.3
0.75 mg rhPDGF-BB39.3± 21.7
1.5 mg rhPDGF-BB32.2± 23.9
3.0 mg rhPDGF-BB43.4± 24.3
Week 8
GroupValue95% CI
Placebo Control25.2± 15.2
0.45 mg rhPDGF-BB26.9± 17.4
0.75 mg rhPDGF-BB28.9± 15.1
1.5 mg rhPDGF-BB25.4± 21
3.0 mg rhPDGF-BB28.6± 24.9
Week 12
GroupValue95% CI
Placebo Control13.5± 8
0.45 mg rhPDGF-BB18.2± 16.4
0.75 mg rhPDGF-BB22.3± 16.4
1.5 mg rhPDGF-BB20.1± 22.7
3.0 mg rhPDGF-BB26.8± 24.8
Week 24
GroupValue95% CI
Placebo Control7.8± 10
0.45 mg rhPDGF-BB12.1± 12.4
0.75 mg rhPDGF-BB16.2± 17.9
1.5 mg rhPDGF-BB16.8± 19.3
3.0 mg rhPDGF-BB22.3± 27.3
Grip Strength Test, All Treated Subjects Primary · 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 pos

Baseline
GroupValue95% CI
Placebo Control42.6± 30.1
0.45 mg rhPDGF-BB33.4± 24.1
0.75 mg rhPDGF-BB47.6± 29.4
1.5 mg rhPDGF-BB39.6± 28.9
3.0 mg rhPDGF-BB39.7± 23.2
Week 4
GroupValue95% CI
Placebo Control40.2± 25.6
0.45 mg rhPDGF-BB44.5± 32
0.75 mg rhPDGF-BB48.3± 33
1.5 mg rhPDGF-BB52± 30.2
3.0 mg rhPDGF-BB41.9± 26.3
Week 8
GroupValue95% CI
Placebo Control53.5± 27.8
0.45 mg rhPDGF-BB50.6± 36.3
0.75 mg rhPDGF-BB64.6± 35
1.5 mg rhPDGF-BB53.3± 29
3.0 mg rhPDGF-BB54.8± 26.4
Week 12
GroupValue95% CI
Placebo Control58.2± 28.1
0.45 mg rhPDGF-BB61± 37.7
0.75 mg rhPDGF-BB67.5± 38.3
1.5 mg rhPDGF-BB61.1± 32.1
3.0 mg rhPDGF-BB45.1± 25.3
Week 24
GroupValue95% CI
Placebo Control66.4± 26.4
0.45 mg rhPDGF-BB69.1± 37.5
0.75 mg rhPDGF-BB79.9± 33.4
1.5 mg rhPDGF-BB69.9± 29.1
3.0 mg rhPDGF-BB62.9± 25.7
Maximum Grip Strength, Treated Subjects Primary · 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 streng

Baseline
GroupValue95% CI
Placebo Control60.4± 35
0.45 mg rhPDGF-BB58.7± 33.1
0.75 mg rhPDGF-BB71.8± 38.9
1.5 mg rhPDGF-BB60.3± 31.2
3.0 mg rhPDGF-BB61.3± 29.7
Week 4
GroupValue95% CI
Placebo Control62.9± 26.2
0.45 mg rhPDGF-BB63.5± 33.1
0.75 mg rhPDGF-BB64.2± 37.2
1.5 mg rhPDGF-BB68.9± 35.5
3.0 mg rhPDGF-BB62± 33
Week 8
GroupValue95% CI
Placebo Control73.3± 29.3
0.45 mg rhPDGF-BB66.4± 31.3
0.75 mg rhPDGF-BB72.9± 37
1.5 mg rhPDGF-BB71.6± 30
3.0 mg rhPDGF-BB66.9± 31.5
Week 12
GroupValue95% CI
Placebo Control78.9± 29.9
0.45 mg rhPDGF-BB68.6± 31.2
0.75 mg rhPDGF-BB81.8± 39.7
1.5 mg rhPDGF-BB74.5± 32.8
3.0 mg rhPDGF-BB65.1± 30
Week 24
GroupValue95% CI
Placebo Control82.5± 32.7
0.45 mg rhPDGF-BB71± 32.5
0.75 mg rhPDGF-BB80.7± 33.7
1.5 mg rhPDGF-BB77.8± 27
3.0 mg rhPDGF-BB76.4± 30.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Patients were assessed through study completion scheduled at 24 weeks following surgery.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Placebo Control
Serious: 0/20 (0%)
Deaths: —
0.45 mg rhPDGF-BB
Serious: 0/20 (0%)
Deaths: —
0.75 mg rhPDGF-BB
Serious: 2/20 (10%)
Deaths: —
1.5 mg rhPDGF-BB
Serious: 0/20 (0%)
Deaths: —
3.0 mg rhPDGF-BB
Serious: 1/20 (5%)
Deaths: —

Serious adverse events (3 terms)

ReactionSystemPlacebo Control0.45 mg rhPDGF-BB0.75 mg rhPDGF-BB1.5 mg rhPDGF-BB3.0 mg rhPDGF-BB
Injection site calcificationGeneral disorders—————
Anaphylactic reactionImmune system disorders—————
Road traffic accidentInjury, poisoning and procedural complications—————
Other adverse events (106 terms — click to expand)

ReactionSystemPlacebo Control0.45 mg rhPDGF-BB0.75 mg rhPDGF-BB1.5 mg rhPDGF-BB3.0 mg rhPDGF-BB
Injection site painGeneral disorders—————
ArthralgiaMusculoskeletal and connective tissue disorders—————
Procedural painInjury, poisoning and procedural complications—————
Injection site swellingGeneral disorders—————
Joint swellingMusculoskeletal and connective tissue disorders—————
Joint range of motion decreasedMusculoskeletal and connective tissue disorders—————
Joint stiffnessMusculoskeletal and connective tissue disorders—————
Joint warmthMusculoskeletal and connective tissue disorders—————
Pain in extremityMusculoskeletal and connective tissue disorders—————
ParaesthesiaNervous system disorders—————
InsomniaPsychiatric disorders—————
Injection site erythemaGeneral disorders—————
Injection site massGeneral disorders—————
Oedema peripheralGeneral disorders—————
Joint crepitationMusculoskeletal and connective tissue disorders—————
Musculoskeletal discomfortMusculoskeletal and connective tissue disorders—————
Musculoskeletal painMusculoskeletal and connective tissue disorders—————
HeadacheNervous system disorders—————
HypoaesthesiaNervous system disorders—————
TremorNervous system disorders—————
Lacrimation increasedEye disorders—————
Abdominal painGastrointestinal disorders—————
ConstipationGastrointestinal disorders—————
DiarrheaGastrointestinal disorders—————
Lip dryGastrointestinal disorders—————
NauseaGastrointestinal disorders—————
ToothacheGastrointestinal disorders—————
VomitingGastrointestinal disorders—————
Feeling hotGeneral disorders—————
Injection site calcificationGeneral disorders—————
Injection site coldnessGeneral disorders—————
Injection site discolourationGeneral disorders—————
Injection site discomfortGeneral disorders—————
Injection site haematomaGeneral disorders—————
Injection site haemorrhageGeneral disorders—————
Injection site inflammationGeneral disorders—————
Injection site pruritusGeneral disorders—————
Injection site rashGeneral disorders—————
Injection site warmthGeneral disorders—————
TendernessGeneral disorders—————

Most-reported serious reactions: Injection site calcification, Anaphylactic reaction, Road traffic accident.

Data from ClinicalTrials.gov NCT01746420 adverse events section.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Lateral Epicondylitis

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01746420.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing