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A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) 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: NCT01124006
Recruitment Status : Completed
First Posted : May 14, 2010
Results First Posted : February 24, 2016
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
DePuy Spine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Degenerative Disc Disease
Interventions Drug: Intradiscal rhGDF-5
Other: Water for injection
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Placebo 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. Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection 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 10 10 4
Completed 7 8 2
Not Completed 3 2 2
Reason Not Completed
Withdrawal by Subject             2             2             0
Lost to Follow-up             1             0             1
Other             0             0             1
Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Placebo 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. Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection 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 10 10 4 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 10 participants 4 participants 24 participants
39.7  (9.56) 44.7  (7.86) 42.4  (6.38) 42.2  (8.40)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 10 participants 4 participants 24 participants
Female
4
  40.0%
3
  30.0%
1
  25.0%
8
  33.3%
Male
6
  60.0%
7
  70.0%
3
  75.0%
16
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 10 participants 4 participants 24 participants
10 10 4 24
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

For the Neurological Assessment at 12 months, only 8 subjects from the rhGDF-5 1.0mg group (out of 10 subjects total) completed the assessment, only 3 subjects from the rhGDF-5 2.0mg group (out of 4 subjects total) completed the assessment, and none of the placebo subjects (out of 10 total subjects) completed the assessment.

Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Placebo 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.
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
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 8 0 3
Measure Type: Number
Unit of Measure: participants
0 0
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 Definitely 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) Placebo 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.
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
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 10 10 4
Measure Type: Number
Unit of Measure: participants
0 0 0
3.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 Possibly or Probably Related to Study Drug.
Time Frame 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) Placebo 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.
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
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 10 10 4
Measure Type: Number
Unit of Measure: participants
4 1 0
4.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-month
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population
Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Placebo 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.
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
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 10 10 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
-19.8  (21.22) -18.8  (22.43) -6.0  (29.98)
5.Secondary Outcome
Title Change in Pain Visual Analogue Scale (VAS) at 12 Months From Baseline.
Hide Description The Visual Analogue Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line ( that is approximately 10cm long) with 'No Pain' (score of 0=0cm) 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
Hide Outcome Measure Data
Hide Analysis Population Description
FAS Population
Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Placebo 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.
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
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 10 10 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.33  (3.645) -2.78  (3.751) -1.10  (3.336)
6.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

One subject from the rhGDF-5 1.0mg group (out of 10 subjects total) did not complete the PCS, SF-36 at Baseline.

Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Placebo 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.
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
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 9 10 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.22  (9.728) 8.61  (14.213) 6.21  (8.245)
7.Secondary Outcome
Title Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-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

One subject from the rhGDF-5 1.0mg group (out of 10 subjects total) did not complete the MCS, SF-36 at Baseline.

Arm/Group Title Intradiscal rhGDF-5 (1.0mg) Placebo 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.
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
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 9 10 4
Mean (Standard Deviation)
Unit of Measure: units on a scale
2.86  (11.142) -0.92  (9.163) 1.31  (20.276)
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) Placebo 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. Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection 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) Placebo Intradiscal rhGDF-5 (2.0mg)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Intradiscal rhGDF-5 (1.0mg) Placebo Intradiscal rhGDF-5 (2.0mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/10 (0.00%)      2/4 (50.00%)    
Musculoskeletal and connective tissue disorders       
Intervertebral Disc Protrusion * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/4 (25.00%)  1
Osteoarthritis * 1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/4 (25.00%)  1
*
Indicates events were collected by non-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) Placebo Intradiscal rhGDF-5 (2.0mg)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/10 (90.00%)      10/10 (100.00%)      4/4 (100.00%)    
Gastrointestinal disorders       
Abdominal Pain Upper  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Diarrhoea  1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/4 (0.00%)  0
Nausea  1  1/10 (10.00%)  2 0/10 (0.00%)  0 0/4 (0.00%)  0
Frequent Bowel Movements  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Haematochezia  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
General disorders       
Injection Site Pain  1  1/10 (10.00%)  1 3/10 (30.00%)  3 1/4 (25.00%)  1
Chills  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Pain  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Pyrexia  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Immune system disorders       
Seasonal Allergy  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/4 (0.00%)  0
Infections and infestations       
Influenza  1  3/10 (30.00%)  4 1/10 (10.00%)  1 0/4 (0.00%)  0
Nasopharyngitis  1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/4 (0.00%)  0
Urinary Tract Infections  1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/4 (0.00%)  0
Ear Infection  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Gastroenteritis Viral  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Herpes Zoster  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/4 (0.00%)  0
Lower Respiratory Tract Infection  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/4 (0.00%)  0
Tooth Abscess  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Upper Respiratory Tract Infection  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/4 (0.00%)  0
Injury, poisoning and procedural complications       
Procedural Pain  1  4/10 (40.00%)  5 0/10 (0.00%)  0 1/4 (25.00%)  1
Joint Sprain  1  1/10 (10.00%)  1 2/10 (20.00%)  2 0/4 (0.00%)  0
Road Traffic Accident  1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/4 (0.00%)  0
Back Injury  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/4 (0.00%)  0
Contusion  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Fall  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/4 (25.00%)  1
Muscle Injury  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Muscle Strain  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/4 (0.00%)  0
Investigations       
Blood Cholesteral Increased  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Blood Urine Present  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Cardiac Murmur  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Lasegue's Test Positive  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back Pain * 1  5/10 (50.00%)  18 6/10 (60.00%)  9 3/4 (75.00%)  6
Arthralgia  1  1/10 (10.00%)  1 3/10 (30.00%)  3 1/4 (25.00%)  4
Pain in Extremity  1  0/10 (0.00%)  0 0/10 (0.00%)  0 3/4 (75.00%)  3
Intervertebral Disc Protrusion  1  0/10 (0.00%)  0 1/10 (10.00%)  1 1/4 (25.00%)  1
Neck Pain  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Arthropathy  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Joint Swelling  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/4 (25.00%)  1
Muscle Tightness  1  1/10 (10.00%)  2 0/10 (0.00%)  0 0/4 (0.00%)  0
Musculoskeletal Pain  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/4 (0.00%)  0
Osteoarthritis  1  0/10 (0.00%)  0 0/10 (0.00%)  0 1/4 (25.00%)  2
Musculoskeletal Stiffness  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Nervous system disorders       
Headache  1  1/10 (10.00%)  1 1/10 (10.00%)  1 0/4 (0.00%)  0
Burning Sensation  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Sciatica  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Syncope  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Psychiatric disorders       
Depression  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/4 (0.00%)  0
Renal and urinary disorders       
Nephrolithiasis  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Oropharyngeal Pain  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Skin and subcutaneous tissue disorders       
Blister  1  1/10 (10.00%)  2 0/10 (0.00%)  0 0/4 (0.00%)  0
Puritus  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/4 (0.00%)  0
Rosacea  1  0/10 (0.00%)  0 1/10 (10.00%)  1 0/4 (0.00%)  0
Skin Lesion  1  1/10 (10.00%)  1 0/10 (0.00%)  0 0/4 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-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
Layout table for Results Point of Contact information
Name/Title: Mark Lotito
Organization: DePuy Synthes Spine
Phone: 508-880-8045
EMail: Mlotito@its.jnj.com
Layout table for additonal information
Responsible Party: DePuy Spine
ClinicalTrials.gov Identifier: NCT01124006     History of Changes
Other Study ID Numbers: 09-Intradiscal rhGDF-5-04
First Submitted: May 11, 2010
First Posted: May 14, 2010
Results First Submitted: December 18, 2015
Results First Posted: February 24, 2016
Last Update Posted: February 24, 2016