Status:
COMPLETED
Intradiscal rhGDF-5 Phase I/II Clinical Trial
Lead Sponsor:
DePuy Spine
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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
Eligibility Criteria
Inclusion
- 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
- Oswestry Disability Index of 30 or greater
- 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
- Persons unable to have a discogram, CT or an MRI
- Abnormal neurological exam at baseline (e.g., radiculopathy)
- Radicular pain
- Leak of contrast agent during the discogram, into the epidural space (does not include leak of contrast agent along the needle track)
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00813813
Start Date
June 1 2008
End Date
June 1 2013
Last Update
February 26 2016
Active Locations (8)
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1
Spine Institute
Santa Monica, California, United States, 90404
2
Durango Orthopedic Associates/Spine Colorado
Durango, Colorado, United States, 81301
3
Drug Studies America
Marietta, Georgia, United States, 30060
4
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611