Clinical trial NCT00813813: Intradiscal rhGDF-5 Phase I/II Clinical Trial
Official title: Phase I/II, Multicenter, Open-label, Single Administration, Dose Finding, Clinical Trial to Evaluate the Safety and Tolerability of Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Degenerative Disc Disease
Lead sponsor: DePuy Spine
Sponsor class: INDUSTRY
First posted: 2008-12-23
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: Inclusion Criteria:

1. 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
2. Oswestry Disability Index of 30 or greater
3. 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

Exclusion Criteria:

1. Persons unable to have a discogram, CT or an MRI
2. Abnormal neurological exam at baseline (e.g., radiculopathy)
3. Radicular pain
4. Leak of contrast agent during the discogram, into the epidural space (does not include leak of contrast agent along the needle track)
5. 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

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
Secondary outcomes:
measure: Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline
timeFrame: 12 months
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: Santa Monica
country: United States
facility: 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: Chicago
country: United States
facility: Rehabilitation Institute of Chicago
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cincinnati
country: United States
facility: Riverhills Healthcare, Inc.
state: Ohio
city: Plano
country: United States
facility: TBI Clinical Research, LLC
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University Spine Center
state: Virginia
Study officials:
affiliation: Massachusetts General Hospital
name: James Rathmell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Texas Back Institute
name: Richard Guyer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Drug Study America
name: Marvin Tark, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Durango Orthopedic Associates/Spine Colorado
name: Jim Youssef, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shirley Ryan AbilityLab
name: Norman Harden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Riverhills Healthcare, Inc.
name: Jonathan Borden, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Yaoming Gu, MD
role: PRINCIPAL_INVESTIGATOR
References: