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Intradiscal rhGDF-5 Phase I/II Clinical Trial

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: NCT00813813
Recruitment Status : Completed
First Posted : December 23, 2008
Results First Posted : January 27, 2016
Last Update Posted : February 26, 2016
Sponsor:
Information provided by (Responsible Party):
DePuy Spine

Tracking Information
First Submitted Date  ICMJE December 22, 2008
First Posted Date  ICMJE December 23, 2008
Results First Submitted Date  ICMJE December 18, 2015
Results First Posted Date  ICMJE January 27, 2016
Last Update Posted Date February 26, 2016
Study Start Date  ICMJE June 2008
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
  • Neurological Assessment for Motor Function and Reflexes/Sensory [ Time Frame: 12 months ]
    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.
  • 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 ]
    Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2008)
To evaluate the safety and tolerability of Intradiscal rhGDF5 in subjects with early lumbar disc degeneration and Investigate the preliminary effectiveness of Intradiscal rhGDF5 in subjects with early lumbar disc degeneration [ Time Frame: duration of the study ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2016)
  • Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline [ Time Frame: 12 months ]
    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.
  • Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline [ Time Frame: 12 months ]
    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.
  • Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline [ Time Frame: 12 Months ]
    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).
  • Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline [ Time Frame: 12 Months ]
    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).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2008)
To test the clinical utility of magnetic resonance imaging (MRI) to evaluate changes in the disc after administration of Intradiscal rhGDF5 [ Time Frame: duration of study ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intradiscal rhGDF-5 Phase I/II Clinical Trial
Official Title  ICMJE Phase I/II, Multicenter, Open-label, Single Administration, Dose Finding, Clinical Trial to Evaluate the Safety and Tolerability of Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
Brief Summary Study to show the effectiveness and safety of a single injection of rhGDF5 into a degenerating single spinal disc in treating lumbar level degenerative disc disease
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Degenerative Disc Disease
Intervention  ICMJE Drug: 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. 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.
Study Arms  ICMJE Experimental: 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. 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.
Intervention: Drug: Intradiscal rhGDF-5
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2016)
32
Original Estimated Enrollment  ICMJE
 (submitted: December 22, 2008)
16
Actual Study Completion Date  ICMJE June 2013
Actual Primary Completion Date June 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Persistent low back pain, with at least 3 months of non-surgical therapy, at one symptomatic lumbar level (L3/L4 to L5/S1) as confirmed using a standardized discography protocol
  2. Oswestry Disability Index of 30 or greater
  3. Low back pain score greater than or equal to 4 cm as measured by VAS, at Visit 1 baseline and on day of treatment to confirm eligibility prior to administration

Exclusion Criteria:

  1. Persons unable to have a discogram, CT or an MRI
  2. Abnormal neurological exam at baseline (e.g., radiculopathy)
  3. Radicular pain
  4. Leak of contrast agent during the discogram, into the epidural space (does not include leak of contrast agent along the needle track)
  5. MRI findings demonstrate any of the following:· Suspected disc appears normal· >50% decrease in disc height· Modic changes, and/or· Presence of osteophytes or significant facet arthrosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00813813
Other Study ID Numbers  ICMJE 07-Intradiscal rhGDF-5-01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party DePuy Spine
Study Sponsor  ICMJE DePuy Spine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: James Rathmell, MD Massachusetts General Hospital
Principal Investigator: Richard Guyer, MD Texas Back Institute
Principal Investigator: Marvin Tark, MD Drug Study America
Principal Investigator: Jim Youssef, MD Durango Orthopedic Associates/Spine Colorado
Principal Investigator: Norman Harden, MD Shirley Ryan AbilityLab
Principal Investigator: Jonathan Borden, MD Riverhills Healthcare, Inc.
Principal Investigator: Yaoming Gu, MD Virginia Commonwealth University
PRS Account DePuy Spine
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP