Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: May 22, 2014
Last verified: May 2014

July 1, 2010
May 22, 2014
March 2010
March 2014   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01158924 on ClinicalTrials.gov Archive Site
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)
Same as current
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 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
No
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT01158924
09-Intradiscal rhGDF-5-02
No
DePuy Spine
DePuy Spine
Janssen-Cilag Pty Ltd
Not Provided
DePuy Spine
May 2014

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