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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01158924
Registration number
NCT01158924
Ethics application status
Date submitted
1/07/2010
Date registered
8/07/2010
Date last updated
26/02/2016
Titles & IDs
Public title
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
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Scientific 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
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Secondary ID [1]
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09-Intradiscal rhGDF-5-02
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Early Lumbar Disc Degeneration
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Intradiscal rhGDF-5
Experimental: Intradiscal rhGDF-5 - The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration.
Treatment: Drugs: Intradiscal rhGDF-5
The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Neurological Assessment for Motor Function and Reflexes/Sensory
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Assessment method [1]
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Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months.
For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance.
For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs.
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Timepoint [1]
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12 months
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Primary outcome [2]
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Treatment Emergent Adverse Events- Relationship to Study Drug
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Assessment method [2]
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Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.
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Timepoint [2]
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Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.
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Secondary outcome [1]
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Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline
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Assessment method [1]
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The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.
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Assessment method [2]
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The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.
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Assessment method [3]
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The 36-item Short Form Health Survey (SF-36) is a patient reported outcome survey that evaluates functional health and well-being. The survey is converted into two summary measures (the Physical Component - PCS and Mental Component- MCS) that are scored from 0 to 100 (where 100 indicates the highest level of health).
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Timepoint [3]
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12 Months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
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Allocation to intervention
N/A
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2014
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
NSW,QLD
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Recruitment hospital [1]
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Hunter Clinical Research - Broadmeadow
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Recruitment hospital [2]
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St. George Private Hospital - Kogarah
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Recruitment hospital [3]
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BrizBain & Spine, The Wesley Hospital - Auchenflower
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Recruitment postcode(s) [1]
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2292 - Broadmeadow
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Recruitment postcode(s) [2]
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2217 - Kogarah
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Recruitment postcode(s) [3]
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4066 - Auchenflower
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
DePuy Spine
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Janssen-Cilag Pty Ltd
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5
in subjects with early lumbar disc degeneration.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01158924
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01158924
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