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Intradiscal rhGDF-5 Phase I/II Clinical Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00813813
First Posted: December 23, 2008
Last Update Posted: February 26, 2016
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.
Information provided by (Responsible Party):
DePuy Spine
December 22, 2008
December 23, 2008
December 18, 2015
January 27, 2016
February 26, 2016
June 2008
June 2013   (Final data collection date for primary outcome measure)
  • 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.
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 ]
Complete list of historical versions of study NCT00813813 on ClinicalTrials.gov Archive Site
  • 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).
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 ]
Not Provided
Not Provided
 
Intradiscal rhGDF-5 Phase I/II Clinical Trial
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
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
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Degenerative Disc Disease
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.
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
June 2013
June 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00813813
07-Intradiscal rhGDF-5-01
Yes
Not Provided
Not Provided
DePuy Spine
DePuy Spine
Not Provided
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
DePuy Spine
January 2016

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