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 Korea, Ltd., Korea
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 suspected symptomatic lumbar level (L3/L4 to L5/S1) as confirmed using a standardized 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, with an expiry of 12 months from the date performed.
- 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 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
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01182337
Start Date
June 1 2010
End Date
June 1 2014
Last Update
February 26 2016
Active Locations (7)
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1
Yeungnam University Medical Center
Daegu, South Korea
2
Asan Medical Center
Seoul, South Korea
3
Gangnam Severance Hospital
Seoul, South Korea
4
Korea University Anam Hospital
Seoul, South Korea