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

This study has been completed.
Sponsor:
Collaborator:
Janssen-Cilag Pty Ltd
Information provided by (Responsible Party):
DePuy Spine
ClinicalTrials.gov Identifier:
NCT01158924
First received: July 1, 2010
Last updated: January 26, 2016
Last verified: January 2016
Results First Received: December 18, 2015  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label
Condition: Early Lumbar Disc Degeneration
Intervention: Drug: Intradiscal rhGDF-5

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Intradiscal rhGDF-5 (1.0mg)     Intradiscal rhGDF-5 (2.0mg)  
STARTED     14     26  
COMPLETED     13     23  
NOT COMPLETED     1     3  
Withdrawal by Subject                 1                 2  
Lost to Follow-up                 0                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
    Intradiscal rhGDF-5 (1.0mg)     Intradiscal rhGDF-5 (2.0mg)     Total  
Number of Participants  
[units: participants]
  14     26     40  
Age  
[units: years]
Mean (Standard Deviation)
  44.2  (10.85)     48.3  (10.37)     46.9  (10.59)  
Gender  
[units: participants]
     
Female     8     11     19  
Male     6     15     21  
Region of Enrollment  
[units: participants]
     
Australia     14     26     40  



  Outcome Measures
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1.  Primary:   Neurological Assessment for Motor Function and Reflexes/Sensory   [ Time Frame: 12 months ]

2.  Primary:   Treatment Emergent Adverse Events- Relationship 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. ]

3.  Secondary:   Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline   [ Time Frame: 12 months ]

4.  Secondary:   Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.   [ Time Frame: 12 months ]

5.  Secondary:   Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.   [ Time Frame: 12 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Mark Lotito
Organization: DePuy Synthes Spine
phone: 508-880-8045
e-mail: mlotito@its.jnj.com



Responsible Party: DePuy Spine
ClinicalTrials.gov Identifier: NCT01158924     History of Changes
Other Study ID Numbers: 09-Intradiscal rhGDF-5-02
Study First Received: July 1, 2010
Results First Received: December 18, 2015
Last Updated: January 26, 2016
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration