Phase 2 N=32 Treatment

Intradiscal rhGDF-5 Phase I/II Clinical Trial

Degenerative Disc Disease

Bottom Line

View on ClinicalTrials.gov: NCT00813813 ↗

Enrolled (actual)

Serious AEs

12.5%

Results posted

Jan 2016

Primary outcome: Primary: Neurological Assessment for Motor Function and Reflexes/Sensory — 0; 0 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Intradiscal rhGDF-5 (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: DePuy Spine
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Neurological Assessment for Motor Function and Reflexes/Sensory	0; 0	—
PRIMARY Treatment Emergent Adverse Events- Relationship to Study Drug	2; 1	—
SECONDARY Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline	-10.0; -17.0	—
SECONDARY Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline	-2.0; -3.0	—
SECONDARY Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline	5.0; 8.0	—
SECONDARY Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline	7.0; 3	—

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

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
Oswestry Disability Index of 30 or greater
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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00813813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.