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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

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

July 1, 2010
January 26, 2016
March 2010
March 2014   (final data collection date for primary outcome measure)
  • Neurological Assessment for Motor Function and Reflexes/Sensory [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

    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. ] [ Designated as safety issue: Yes ]
    Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.
Evaluate the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration [ Time Frame: Through a 36 month period ] [ Designated as safety issue: No ]
Clinical outcome measurements and safety outcomes (adverse events, neurological status, and standard laboratory results of CBC, blood chemistry and rhGDF-5 antibody analysis)
Complete list of historical versions of study NCT01158924 on ClinicalTrials.gov Archive Site
  • Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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).
Investigate the preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration [ Time Frame: Through a 36 month period ] [ Designated as safety issue: No ]
Clinical outcome measurements and safety outcomes (adverse events, neurological status, and standard laboratory results of CBC, blood chemistry and rhGDF-5 antibody analysis)
Not Provided
Not Provided
 
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
A Phase I/IIa, Multicenter, Open-label, 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
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.
Not Provided
Interventional
Phase 1
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Early Lumbar Disc Degeneration
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
40
March 2014
March 2014   (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 or two suspected symptomatic lumbar levels (L3/L4 to L5/S1)

    a. The recruiting physician will use their standard clinical and radiological practice to determine the one/two disc level(s) be treated, i.e., but not limited to a combination of MRI, CT and/or Technetium bone scans, functional x-rays, input from a spinal injection program (targeting facet joints and/or epidural space) and discography (a discogram performed within 12 months of the anticipated study treatment date is acceptable, as long as the subject has not had an accident or re-injury).

  2. Oswestry Disability Index (ODI) for low back pain of 30 or greater
  3. Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale (VAS) at Visit 1 Baseline
  4. Male or Female 18 years of age or older

Exclusion Criteria:

  1. Persons unable to have an MRI
  2. Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
  3. Persons with neurological or radiographic evidence of active radicular pain due to anatomical compression such as stenosis or disc herniation (persons with somatic referred pain are allowed)
  4. Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level(s) or adjacent segments
  5. Suspected symptomatic sacro-iliac joint
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01158924
09-Intradiscal rhGDF-5-02
No
Not Provided
Not Provided
DePuy Spine
DePuy Spine
Janssen-Cilag Pty Ltd
Not Provided
DePuy Spine
January 2016

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