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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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
DePuy Spine
ClinicalTrials.gov Identifier:
NCT01124006
First received: May 11, 2010
Last updated: June 23, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Degenerative Disc Disease
Drug: Intradiscal rhGDF-5
Other: Water for injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by DePuy Spine:

Primary Outcome Measures:
  • Evaluate the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration [ Time Frame: Through a 12-month period and annual telephone contact at 24 and 36 months for subject health status follow-up ] [ Designated as safety issue: Yes ]
    Clinical outcome measurements and safety outcomes (adverse events, neurological status, and standard lab results of CBC, blood chemistry and rhGDF-5 antibody analysis)


Secondary Outcome Measures:
  • Investigate the preliminary effectiveness of Intradiscal rhGDF-5 as compared to placebo in subjects with early lumbar disc degeneration [ Time Frame: Through a 12-month period and annual telephone contact at 24 and 36 months for subject health status follow-up ] [ Designated as safety issue: Yes ]
    Clinical outcome measurements and safety outcomes (adverse events, neurological status, and standard lab results of CBC, blood chemistry and rhGDF-5 antibody analysis)


Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: 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.
Placebo Comparator: Water for injection
Sterile water for injection
Other: Water for injection
Sterile water for injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  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

Exclusion Criteria:

  1. Persons unable to have a discogram, CT, or MRI
  2. Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
  3. Active radicular pain due to anatomical compression such as stenosis or disc herniation (radicular pain is defined as pain below the knee)
  4. 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)
  5. Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level or adjacent segments
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124006

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

No publications provided

Responsible Party: DePuy Spine
ClinicalTrials.gov Identifier: NCT01124006     History of Changes
Other Study ID Numbers: 09-Intradiscal rhGDF-5-04
Study First Received: May 11, 2010
Last Updated: June 23, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014