Degenerative Disc DiseasePhase 2NCT01124006

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

A Phase 2 study testing Intradiscal rhGDF-5 and Water for injection in people with Degenerative Disc Disease, run by DePuy Spine at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Degenerative Disc Disease
What is being tested?: Intradiscal rhGDF-5 and Water for injection
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 10 sitesUnited States
Study dates: Jan 2010to Sep 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Oswestry Disability Index (ODI) for low back pain of 30 or greater
Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale (VAS) at Visit 1 Baseline

Who cannot join

Persons unable to have a discogram, CT, or MRI
Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
Active radicular pain due to anatomical compression such as stenosis or disc herniation (radicular pain is defined as pain below the knee)
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)
Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level or adjacent segments

Trial locations and contacts

10 sites in 1 country.

City, postcode or hospital

10 sites in 1 country

United States10 sites

Medical University of South Carolina
Charleston, South Carolina, 29401
Durango Orthopedic Associates/Spine Colorado
Durango, Colorado, 81301
University of Kansas Medical Center
Kansas City, Kansas, 66160
Drug Studies America
Marietta, Georgia, 30060
Hospital for Special Surgery
New York, New York, 10021
Hope Research Institute
Phoenix, Arizona, 85050
The Spine Institute
Santa Monica, California, 90404
Spine Team Texas
Southlake, Texas, 76092
University Orthopedics Center
State College, Pennsylvania, 16801
Texas Spine & Joint Hospital
Tyler, Texas, 75701

Other trials in United States

About this study

Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration

Conditions: Degenerative Disc Disease
Being tested: Intradiscal rhGDF-5, Water for injection
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intradiscal rhGDF-5Drug
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.
Water for injectionOther
Sterile water for injection

Study groups in NCT01124006
Study group	Role	What they receive
Intradiscal rhGDF-5	Experimental	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. Receives: Drug: Intradiscal rhGDF-5
Water for injection	Placebo comparator	Sterile water for injection Receives: Other: Water for injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Neurological Assessment for Motor Function and Reflexes/Sensory
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.
Measured: 12 months
Treatment Emergent Adverse Events- Relationship to Study Drug
Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.
Measured: Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.
Treatment Emergent Adverse Events- Relationship to Study Drug
Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.
Measured: 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up

Secondary outcomes (4)

Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.
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.
Measured: 12-month
Change in Pain Visual Analogue Scale (VAS) at 12 Months From Baseline.
The Visual Analogue Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line ( that is approximately 10cm long) with 'No Pain' (score of 0=0cm) 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.
Measured: 12 months
Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.
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)
Measured: 12 months
Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.
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)
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2010Sep 2014

First posted14 May 2010 (estimated)
Study startJan 2010
Primary completionSep 2014
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01124006
Sponsor's protocol ID: 09-Intradiscal rhGDF-5-04
Status last verified: Jan 2016
First submitted: 11 May 2010
Last updated: 24 Feb 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc Disease, Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy

All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01124006
Acronym / sponsor ID: 09-Intradiscal rhGDF-5-04
Conditions: Degenerative Disc Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: DePuy SpineIndustry (pharma, biotech, devices)
Study start: Jan 2010
Primary completion: Sep 2014 (actual)
Study completion: Sep 2014 (actual)
First posted: 14 May 2010 (estimated)
Results: Posted 24 Feb 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study to show the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Intradiscal rhGDF-5	Experimental	Drug: Intradiscal rhGDF-5The 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.
Water for injection	Placebo comparator	Other: Water for injectionSterile water for injection

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.
Oswestry Disability Index (ODI) for low back pain of 30 or greater
Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale (VAS) at Visit 1 Baseline

Key exclusion criteria (5 listed)

Persons unable to have a discogram, CT, or MRI
Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
Active radicular pain due to anatomical compression such as stenosis or disc herniation (radicular pain is defined as pain below the knee)
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)
Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level or adjacent segments

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intradiscal rhGDF-5The 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.	Drug	Intradiscal rhGDF-5
Water for injectionSterile water for injection	Other	Water for injection

Primary outcome

Neurological Assessment for Motor Function and Reflexes/Sensory
Time frame: 12 months
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.
Treatment Emergent Adverse Events- Relationship to Study Drug
Time frame: Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.
Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.
Treatment Emergent Adverse Events- Relationship to Study Drug
Time frame: 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up
Number of patients with Treatment Emergent Adverse Events that were designated as Possibly or Probably Related to Study Drug.

4 secondary outcomes

Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.
Time frame: 12-month
Change in Pain Visual Analogue Scale (VAS) at 12 Months From Baseline.
Time frame: 12 months
Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.
Time frame: 12 months
Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.
Time frame: 12 months

Results and safety

Results posted to the registry on 24 Feb 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intradiscal rhGDF-5 (1.0mg)	10	7
Placebo	10	8
Intradiscal rhGDF-5 (2.0mg)	4	2

Primary outcome: Neurological Assessment for Motor Function and Reflexes/Sensory

Time frame: 12 months. Number. Unit: participants

Measure	Intradiscal rhGDF-5 (1.0mg) n = 8	Placebo n = 0	Intradiscal rhGDF-5 (2.0mg) n = 3
Value	0	–	0

Population analysed: Safety Population For the Neurological Assessment at 12 months, only 8 subjects from the rhGDF-5 1.0mg group (out of 10 subjects total) completed the assessment, only 3 subjects from the rhGDF-5 2.0mg group (out of 4 subjects total) completed the assessment, and none of the placebo subjects (out of 10 total subjects) completed the assessment.

Primary outcome: Treatment Emergent Adverse Events- Relationship to Study Drug

Time frame: Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up.. Number. Unit: participants

Measure	Intradiscal rhGDF-5 (1.0mg) n = 10	Placebo n = 10	Intradiscal rhGDF-5 (2.0mg) n = 4
Value	0	0	0

Population analysed: Safety Population

Primary outcome: Treatment Emergent Adverse Events- Relationship to Study Drug

Time frame: 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up. Number. Unit: participants

Measure	Intradiscal rhGDF-5 (1.0mg) n = 10	Placebo n = 10	Intradiscal rhGDF-5 (2.0mg) n = 4
Value	4	1	0

Population analysed: Safety Population

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intradiscal rhGDF-5 (1.0mg)	0 of 10 (0%)	9 of 10 (90%)	Not reported
Placebo	0 of 10 (0%)	10 of 10 (100%)	Not reported
Intradiscal rhGDF-5 (2.0mg)	2 of 4 (50%)	4 of 4 (100%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Degenerative Disc Disease

RecruitingObservational study
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc Disease, Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion
Enrolling by invitationObservational study
INDUCE: A Prospective 2-Year Spine Registry
Subjects Treated With NMP as Part of Their Spine Surgery, Degenerative Disc Disease (DDD)
Enrolling by invitation
Assessing Microbiome in Primary Anterior Cervical Fusion Patients
Cervical Stenosis, Myelopathy

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

10 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Intradiscal rhGDF-5 and Water for injection in people with Degenerative Disc Disease, run by DePuy Spine at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurological Assessment for Motor Function and Reflexes/Sensory (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01124006.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.