Clinical trial NCT01182337: 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
Official title: A Multicenter, Randomized, Double-blind, Placebo Controlled, 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Early Lumbar Disc Degeneration
Lead sponsor: DePuy Spine
Sponsor class: INDUSTRY
Collaborators: name: Janssen Korea, Ltd., Korea
First posted: 2010-08-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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 Criteria:

1. 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.
2. Oswestry Disability Index (ODI) for low back pain of 30 or greater
3. Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale (VAS) at Visit 1 Baseline
4. Male or Female 18 years of age or older

Exclusion Criteria:

1. Persons unable to have a discogram, CT, or MRI
2. Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
3. Active radicular pain due to anatomical compression such as stenosis or disc herniation (radicular pain is defined as pain below the knee)
4. 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)
5. Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level or adjacent segments

Primary outcomes:
measure: Neurological Assessment for Motor Function and Reflexes/Sensory
timeFrame: 12 months
measure: Treatment Emergent Adverse Events- Relationship to Study Drug
timeFrame: Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up
measure: Treatment Emergent Adverse Events- Relationship to Study Drug
timeFrame: 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up
Secondary outcomes:
measure: Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.
timeFrame: 12 month
measure: Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.
timeFrame: 12 months
measure: Change in Physical Component Summary of Quality of Life Measure Assessed by Short Form 36 at 12 Months From Baseline
timeFrame: 12 months
measure: Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.
timeFrame: 12 Months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System
Study officials:
References:
citation: Adoungotchodo A, Epure LM, Mwale F, Lerouge S. Chitosan-based hydrogels supplemented with gelatine and Link N enhance extracellular matrix deposition by encapsulated cells in a degenerative intervertebral disc environment. Eur Cell Mater. 2021 May 4;41:471-484. doi: 10.22203/eCM.v041a30.