Intradiscal rhGDF-5 Phase I/II Clinical Trial

Completed · Phase 1/Phase 2

Conditions studied: Degenerative Disc Disease

In brief

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

Key facts

Study ID

NCT00813813

Run by

DePuy Spine

People needed

32

Starts

2008-06-01

Expected to finish

2013-06-01

Last updated by the study team

2016-02-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Spine Institute — Santa Monica, California, United States
• Durango Orthopedic Associates/Spine Colorado — Durango, Colorado, United States
• Drug Studies America — Marietta, Georgia, United States
• Rehabilitation Institute of Chicago — Chicago, Illinois, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Riverhills Healthcare, Inc. — Cincinnati, Ohio, United States
• TBI Clinical Research, LLC — Plano, Texas, United States
• Virginia Commonwealth University Spine Center — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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