A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration

Completed · Phase 2

Conditions studied: Degenerative Disc Disease

In brief

Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration

Key facts

Study ID

NCT01124006

Run by

DePuy Spine

People needed

24

Starts

2010-01-01

Expected to finish

2014-09-01

Last updated by the study team

2016-02-24

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 suspected symptomatic lumbar level (L3/L4 to L5/S1) as confirmed using a standardized provocative discography protocol. The required discography protocol will be provided by the sponsor. Subjects with multilevel disease must have a provocative discogram confirming that only 1 level is symptomatic at least 2 weeks prior to administration. Historical provocative discograms may be used for screening purposes, with an expiry of 12 calendar months from the date performed. If the study treatment is not performed within those 12 calendar months, a new discogram will be required.
• 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

You may not qualify if…

• Persons unable to have a discogram, CT, or MRI
• Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
• Active radicular pain due to anatomical compression such as stenosis or disc herniation (radicular pain is defined as pain below the knee)
• Extravasation of contrast agent during the discogram, into the epidural space (does not include leakage of contrast agent along the needle track or leakage to the outer annular ring at the posterior longitudinal ligament vicinity)
• Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level or adjacent segments

Where it is running

• Hope Research Institute — Phoenix, Arizona, United States
• The Spine Institute — Santa Monica, California, United States
• Durango Orthopedic Associates/Spine Colorado — Durango, Colorado, United States
• Drug Studies America — Marietta, Georgia, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• Hospital for Special Surgery — New York, New York, United States
• University Orthopedics Center — State College, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Spine Team Texas — Southlake, Texas, United States
• Texas Spine & Joint Hospital — Tyler, Texas, United States

Full record on ClinicalTrials.gov

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