Clinical Trial: 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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary: Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.

Detailed Summary:
Sponsor: DePuy Spine

Current 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 related or possibly related to Study Drug.

Original Primary Outcome: Evaluate the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration [ Time Frame: Through a 36 month period ]

Current Secondary Outcome:

• Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline [ Time Frame: 12 months ]
  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.
• Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline. [ Time Frame: 12 months ]
  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.
• Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline. [ Time Frame: 12 Months ]
  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).

Original Secondary Outcome: Investigate the preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration [ Time Frame: Through a 36 month period ]

Dates:
Date Received: July 1, 2010
Date Started: March 2010
Date Completion:
Last Updated: January 26, 2016
Last Verified: January 2016