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Study to show the effectiveness and safety of a single injection of rhGDF5 into a degenerating single spinal disc in treating lumbar level degenerative disc disease
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intradiscal rhGDF-5 | Experimental | The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intradiscal rhGDF-5 | Drug | The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurological Assessment for Motor Function and Reflexes/Sensory | Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months. For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance. For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs. | 12 months |
| Treatment Emergent Adverse Events- Relationship to Study Drug | Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug. | Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline | The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Rathmell, MD | Massachusetts General Hospital | Principal Investigator |
| Richard Guyer, MD | Texas Back Institute | Principal Investigator |
| Marvin Tark, MD | Drug Study America | Principal Investigator |
| Jim Youssef, MD | Durango Orthopedic Associates/Spine Colorado | Principal Investigator |
| Norman Harden, MD | Shirley Ryan AbilityLab | Principal Investigator |
| Jonathan Borden, MD | Riverhills Healthcare, Inc. | Principal Investigator |
| Yaoming Gu, MD | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spine Institute | Santa Monica | California | 90404 | United States | ||
| Durango Orthopedic Associates/Spine Colorado |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intradiscal rhGDF-5 (0.25mg) | The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. |
| FG001 | Intradiscal rhGDF-5 (1.0mg) | The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intradiscal rhGDF-5 (0.25mg) | The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Neurological Assessment for Motor Function and Reflexes/Sensory | Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months. For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance. For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs. | Safety Population | Posted | Number | participants | 12 months |
|
Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intradiscal rhGDF-5 (0.25mg) | The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Lotito | DePuy Synthes Spine | 508-880-8045 | mlotito@its.jnj.com |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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|
| 12 months |
| Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline | The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back. | 12 months |
| Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline | The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health). | 12 Months |
| Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline | The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health). | 12 Months |
| Durango |
| Colorado |
| 81301 |
| United States |
| Drug Studies America | Marietta | Georgia | 30060 | United States |
| Rehabilitation Institute of Chicago | Chicago | Illinois | 60611 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Riverhills Healthcare, Inc. | Cincinnati | Ohio | 45242 | United States |
| TBI Clinical Research, LLC | Plano | Texas | 75093 | United States |
| Virginia Commonwealth University Spine Center | Richmond | Virginia | 23235 | United States |
| Other |
|
| BG001 | Intradiscal rhGDF-5 (1.0mg) | The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
| OG001 | Intradiscal rhGDF-5 (1.0mg) | The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. |
|
|
| Secondary | Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline | The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale. | FAS Population | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Primary | Treatment Emergent Adverse Events- Relationship to Study Drug | Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug. | Safety Population | Posted | Number | participants | Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up |
|
|
|
| Secondary | Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline | The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back. | FAS Population | Posted | Mean | Standard Deviation | units on a scale | 12 months |
|
|
|
| Secondary | Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline | The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health). | FAS Population | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
|
|
|
| Secondary | Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline | The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health). | FAS Population | Posted | Mean | Standard Deviation | units on a scale | 12 Months |
|
|
|
| 2 |
| 7 |
| 7 |
| 7 |
| EG001 | Intradiscal rhGDF-5 (1.0mg) | The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. | 2 | 25 | 24 | 25 |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ovarian Mass | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Joint Instability | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Rotator Cuff Syndrome | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Procedural Pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Accidental Needle Stick | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection Site Pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Injection Site Bruising | General disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
|
| White Blood Cell Count Decreased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Mood Swings | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Paranoia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Endometriosis | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Ovarian Mass | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Angina Pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Clinical Investigators may freely present or publish results of the Clinical Investigation in a manner which fairly sets forth the conclusions reached by the Clinical Investigators, but only after the Sponsor has been given the opportunity of reviewing the proposed presentation or publication at least 60 days prior to the intended submission, presentation, or publication date.