A Multicenter, Randomized, Double-blind, Placebo Controlled, 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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- DePuy Spine
- 入组人数
- 31
- 试验地点
- 7
- 主要终点
- Neurological Assessment for Motor Function and Reflexes/Sensory
研究概览
简要总结
Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 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, with an expiry of 12 months from the date performed.
- •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
- •Male or Female 18 years of age or older
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Intradiscal rhGDF-5 (Drug)
Vehicle control
Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
干预措施: Vehicle control (Drug)
结局指标
主要结局
Neurological Assessment for Motor Function and Reflexes/Sensory
时间窗: 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
时间窗: 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.
次要结局
- Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-36 at 12 Months From Baseline.(12 Months)
- Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline.(12 month)
- Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline.(12 months)
- Change in Physical Component Summary of Quality of Life Measure Assessed by Short Form 36 at 12 Months From Baseline(12 months)