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 is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Janssen-Cilag Pty Ltd

Information provided by (Responsible Party):

DePuy Spine

ClinicalTrials.gov Identifier:

NCT01158924

First received: July 1, 2010

Last updated: February 15, 2013

Last verified: February 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	July 1, 2010
Last Updated Date	February 15, 2013
Start Date ^ICMJE	March 2010
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: July 7, 2010)	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)
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01158924 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 7, 2010)	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)
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	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
Official Title ^ICMJE	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
Brief Summary	Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Intervention Model: Single Group Assignment Masking: Open Label
Condition ^ICMJE	Early Lumbar Disc Degeneration
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 Arm (s)	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	Active, not recruiting
Estimated Enrollment ^ICMJE	38
Estimated Completion Date	March 2014
Estimated Primary Completion Date	June 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: 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). Oswestry Disability Index (ODI) for low back pain of 30 or greater Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale (VAS) at Visit 1 Baseline Male or Female 18 years of age or older Exclusion Criteria: Persons unable to have an MRI Abnormal neurological exam at baseline (e.g., chronic radiculopathy) 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) Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level(s) or adjacent segments Suspected symptomatic sacro-iliac joint
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Australia

Administrative Information
NCT Number ^ICMJE	NCT01158924
Other Study ID Numbers ^ICMJE	09-Intradiscal rhGDF-5-02
Has Data Monitoring Committee	No
Responsible Party	DePuy Spine
Study Sponsor ^ICMJE	DePuy Spine
Collaborators ^ICMJE	Janssen-Cilag Pty Ltd
Investigators ^ICMJE	Not Provided
Information Provided By	DePuy Spine
Verification Date	February 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top