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| Name | Class |
|---|---|
| Janssen Korea, Ltd., Korea | 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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| Vehicle control | Placebo Comparator | Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection |
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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 Definitely Related to Study Drug. | Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up |
| Treatment Emergent Adverse Events- Relationship to Study Drug | Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug. | 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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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeungnam University Medical Center | Daegu | South Korea | ||||
| Asan Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33945627 | Derived | Adoungotchodo A, Epure LM, Mwale F, Lerouge S. Chitosan-based hydrogels supplemented with gelatine and Link N enhance extracellular matrix deposition by encapsulated cells in a degenerative intervertebral disc environment. Eur Cell Mater. 2021 May 4;41:471-484. doi: 10.22203/eCM.v041a30. |
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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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| Vehicle control | Drug | Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection |
|
| 12 month |
| 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 |
| Seoul |
| South Korea |
| Gangnam Severance Hospital | Seoul | South Korea |
| Korea University Anam Hospital | Seoul | South Korea |
| Seoul National University Hospital | Seoul | South Korea |
| Seoul St. Mary Hospital | Seoul | South Korea |
| Yonsei University Health System | Seoul | South Korea |
| FG001 | Vehicle Control | Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intradiscal rhGDF-5 | 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 | Vehicle Control | Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection |
| 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 For the Neurological Assessment at 12 months, only 21 subjects from the rhGDF-5 group completed the assessment (out of 22 total subjects) and 5 subjects from the Control group completed the assessment (out of 9 subjects 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 month |
| ||||||||||||||||||||||||||||||
| Primary | Treatment Emergent Adverse Events- Relationship to Study Drug | Number of patients with Treatment Emergent Adverse Events that were designated as Definitely 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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| Primary | Treatment Emergent Adverse Events- Relationship to Study Drug | Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug. | Safety Population | Posted | Number | participants | 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 |
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| 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 Only 21 subjects from the rhGDF-5 group (out of 22 total subjects) completed the baseline PCS, SF-36. | Posted | Mean | Standard Deviation | units on a scale | 12 months |
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| 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 Only 21 subjects from the rhGDF-5 group (out of 22 subjects total) completed the MCS, SF-36. | 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 | 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. | 5 | 22 | 16 | 22 | ||
| EG001 | Vehicle Control | Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection | 2 | 9 | 5 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Meniscus Lesion | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Muscle Injury | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Muscle Strain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Vertigo Positional | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | 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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| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Intervertebral Disc Protrusion | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
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| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Dermatitis Contact | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Diabetes Mellitus | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Varicose Vein | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Vertigo Positional | Ear and labyrinth disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Hepatic Steatosis | Hepatobiliary disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Trigger Finger | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
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| Muscle Strain | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal 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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