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A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01158924
Recruitment Status : Completed
First Posted : July 8, 2010
Results First Posted : January 27, 2016
Last Update Posted : February 26, 2016
Sponsor:
Collaborator:
Janssen-Cilag Pty Ltd
Information provided by (Responsible Party):
DePuy Spine

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Early Lumbar Disc Degeneration
Intervention Drug: Intradiscal rhGDF-5
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Intradiscal rhGDF-5 (2.0mg)
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 14 26
Completed 13 23
Not Completed 1 3
Reason Not Completed
Withdrawal by Subject             1             2
Lost to Follow-up             0             1
Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Intradiscal rhGDF-5 (2.0mg) Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 14 26 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 26 participants 40 participants
44.2  (10.85) 48.3  (10.37) 46.9  (10.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 26 participants 40 participants
Female
8
  57.1%
11
  42.3%
19
  47.5%
Male
6
  42.9%
15
  57.7%
21
  52.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Australia Number Analyzed 14 participants 26 participants 40 participants
14 26 40
1.Primary Outcome
Title Neurological Assessment for Motor Function and Reflexes/Sensory
Hide Description

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.

Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description

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).

Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Intradiscal rhGDF-5 (2.0mg)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 13 25
Measure Type: Number
Unit of Measure: participants
0 2
2.Primary Outcome
Title Treatment Emergent Adverse Events- Relationship to Study Drug
Hide Description Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.
Time Frame Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Intradiscal rhGDF-5 (2.0mg)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Measure Type: Number
Unit of Measure: participants
2 1
3.Secondary Outcome
Title Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline
Hide Description 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.
Time Frame 12 months
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Hide Analysis Population Description
FAS Population
Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Intradiscal rhGDF-5 (2.0mg)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
-13.0  (14.63) -18.1  (13.69)
4.Secondary Outcome
Title Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.
Hide Description 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.
Time Frame 12 months
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Hide Analysis Population Description
FAS Population
Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Intradiscal rhGDF-5 (2.0mg)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.66  (3.448) -3.80  (2.651)
5.Secondary Outcome
Title Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.
Hide Description 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).
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population
Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Intradiscal rhGDF-5 (2.0mg)
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 14 26
Mean (Standard Deviation)
Unit of Measure: units on a scale
11.18  (13.206) 10.00  (9.897)
Time Frame Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Intradiscal rhGDF-5 (2.0mg)
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Intradiscal rhGDF-5 (1.0mg) Intradiscal rhGDF-5 (2.0mg)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intradiscal rhGDF-5 (1.0mg) Intradiscal rhGDF-5 (2.0mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      4/26 (15.38%)    
Cardiac disorders     
Angina Pectoris  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain  1  0/14 (0.00%)  0 1/26 (3.85%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate Cancer  1  0/14 (0.00%)  0 1/26 (3.85%)  1
Small cell lung cancer  1  0/14 (0.00%)  0 1/26 (3.85%)  1
Nervous system disorders     
Guillain-Barre Syndrome  1  0/14 (0.00%)  0 1/26 (3.85%)  1
Migraine  1  0/14 (0.00%)  0 1/26 (3.85%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intradiscal rhGDF-5 (1.0mg) Intradiscal rhGDF-5 (2.0mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/14 (85.71%)      18/26 (69.23%)    
Cardiac disorders     
Angina Pectoris  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Gastrointestinal disorders     
Vomiting  1  4/14 (28.57%)  4 1/26 (3.85%)  1
Constipation  1  1/14 (7.14%)  1 2/26 (7.69%)  2
Diarrhoea  1  1/14 (7.14%)  1 2/26 (7.69%)  2
Nausea  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Immune system disorders     
Seasonal Allergy  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Infections and infestations     
Influenza  1  0/14 (0.00%)  0 2/26 (7.69%)  2
Lower Respiratory Tract Infection  1  1/14 (7.14%)  1 1/26 (3.85%)  1
Nasopharyngitis  1  0/14 (0.00%)  0 2/26 (7.69%)  2
Gastroenteritis  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Pneumonia  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Rhinitis  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Staphlococcal Infection  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  2/14 (14.29%)  3 2/26 (7.69%)  2
Procedural pain  1  3/14 (21.43%)  4 0/26 (0.00%)  0
Investigations     
Hepatic Enzyme Increased  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Metabolism and nutrition disorders     
Hyperglycaemia  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Back Pain  1  3/14 (21.43%)  7 12/26 (46.15%)  20
Neck Pain  1  0/14 (0.00%)  0 2/26 (7.69%)  2
Pain in Extremity  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Nervous system disorders     
Migraine  1  3/14 (21.43%)  5 1/26 (3.85%)  2
Ataxia  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Headache  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Paraesthesia  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Parosmia  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Peripheral Sensorimotor Neuropathy  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Sciatica  1  1/14 (7.14%)  2 0/26 (0.00%)  0
Psychiatric disorders     
Depression  1  0/14 (0.00%)  0 2/26 (7.69%)  2
Insomnia  1  1/14 (7.14%)  1 1/26 (3.85%)  1
Anxiety  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Oropharyngeal Spasm  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Skin and subcutaneous tissue disorders     
Hyperhidrosis  1  1/14 (7.14%)  3 0/26 (0.00%)  0
Pruritus  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Subcutaneous Nodule  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Vascular disorders     
Hypertension  1  1/14 (7.14%)  1 0/26 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unspecified)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Mark Lotito
Organization: DePuy Synthes Spine
Phone: 508-880-8045
Responsible Party: DePuy Spine
ClinicalTrials.gov Identifier: NCT01158924     History of Changes
Other Study ID Numbers: 09-Intradiscal rhGDF-5-02
First Submitted: July 1, 2010
First Posted: July 8, 2010
Results First Submitted: December 18, 2015
Results First Posted: January 27, 2016
Last Update Posted: February 26, 2016