Clinical trial NCT01124006: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Degenerative Disc Disease
Lead sponsor: DePuy Spine
Sponsor class: INDUSTRY
First posted: 2010-05-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to show the safety and tolerability 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 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.
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

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 Analogue 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: Phoenix
country: United States
facility: Hope Research Institute
state: Arizona
city: Santa Monica
country: United States
facility: The Spine Institute
state: California
city: Durango
country: United States
facility: Durango Orthopedic Associates/Spine Colorado
state: Colorado
city: Marietta
country: United States
facility: Drug Studies America
state: Georgia
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Southlake
country: United States
facility: Spine Team Texas
state: Texas
city: Tyler
country: United States
facility: Texas Spine & Joint Hospital
state: Texas
Study officials:
References: