Clinical trial NCT01158924: 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 Phase I/IIa, Multicenter, Open-label, 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-Cilag Pty Ltd
First posted: 2010-07-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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 or two suspected symptomatic lumbar levels (L3/L4 to L5/S1)

   a. The recruiting physician will use their standard clinical and radiological practice to determine the one/two disc level(s) be treated, i.e., but not limited to a combination of MRI, CT and/or Technetium bone scans, functional x-rays, input from a spinal injection program (targeting facet joints and/or epidural space) and discography (a discogram performed within 12 months of the anticipated study treatment date is acceptable, as long as the subject has not had an accident or re-injury).
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 an MRI
2. Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
3. Persons with neurological or radiographic evidence of active radicular pain due to anatomical compression such as stenosis or disc herniation (persons with somatic referred pain are allowed)
4. Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level(s) or adjacent segments
5. Suspected symptomatic sacro-iliac joint

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
Other outcomes:
Locations:
city: Broadmeadow
country: Australia
facility: Hunter Clinical Research
state: New South Wales
city: Kogarah
country: Australia
facility: St. George Private Hospital
state: New South Wales
city: Auchenflower
country: Australia
facility: BrizBain & Spine, The Wesley Hospital
state: Queensland
Study officials:
References: