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| Name | Class |
|---|---|
| Janssen-Cilag Pty Ltd | INDUSTRY |
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Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.
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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. |
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| 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:
Persistent low back pain with at least 3 months of non-surgical therapy at one or two suspected symptomatic lumbar levels (L3/L4 to L5/S1)
a. The recruiting physician will use their standard clinical and radiological practice to determine the one/two disc level(s) be treated, i.e., but not limited to a combination of MRI, CT and/or Technetium bone scans, functional x-rays, input from a spinal injection program (targeting facet joints and/or epidural space) and discography (a discogram performed within 12 months of the anticipated study treatment date is acceptable, as long as the subject has not had an accident or re-injury).
Oswestry Disability Index (ODI) for low back pain of 30 or greater
Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale (VAS) at Visit 1 Baseline
Male or Female 18 years of age or older
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunter Clinical Research | Broadmeadow | New South Wales | 2292 | Australia | ||
| St. George Private Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 protein (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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| 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 |
| Kogarah |
| New South Wales |
| 2217 |
| Australia |
| BrizBain & Spine, The Wesley Hospital | Auchenflower | Queensland | 4066 | Australia |
| FG001 | Intradiscal rhGDF-5 (2.0mg) | 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 protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. |
| BG001 | Intradiscal rhGDF-5 (2.0mg) | 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 protein (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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 The Neurological Assessment at 12 months was only conducted on 13 subjects from the 1.0mg group (out of 14 total subjects) and 25 subjects from the 2.0 mg group (out of 26 total). | Posted | Number | participants | 12 months |
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| 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 |
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| 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. |
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| 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 |
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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 (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 protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. | 1 | 14 | 12 | 14 | ||
| EG001 | Intradiscal rhGDF-5 (2.0mg) | 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 protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. | 4 | 26 | 18 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
| |
| Small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
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| Guillain-Barre Syndrome | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Lower Respiratory Tract Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Staphlococcal Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Ataxia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Parosmia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Peripheral Sensorimotor Neuropathy | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Sciatica | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Subcutaneous Nodule | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Oropharyngeal Spasm | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Seasonal Allergy | Immune system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Angina Pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hepatic Enzyme Increased | Investigations | MedDRA (Unspecified) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Lotito | DePuy Synthes Spine | 508-880-8045 | mlotito@its.jnj.com |
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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