Status:
COMPLETED
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
Lead Sponsor:
DePuy Spine
Collaborating Sponsors:
Janssen-Cilag Pty Ltd
Conditions:
Early Lumbar Disc Degeneration
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01158924
Start Date
March 1 2010
End Date
March 1 2014
Last Update
February 26 2016
Active Locations (3)
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1
Hunter Clinical Research
Broadmeadow, New South Wales, Australia, 2292
2
St. George Private Hospital
Kogarah, New South Wales, Australia, 2217
3
BrizBain & Spine, The Wesley Hospital
Auchenflower, Queensland, Australia, 4066