NCT01526330已完成1 期
A Double-blind, Randomized, Parallel, Placebo Controlled, Phase I/II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH14618 Following Single Intradiscal Injection in Patients With Degenerative Disc Disease
Yuhan Corporation1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2012年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Evaulate the safety and tolerability after single intradiscal administation
研究概览
简要总结
The objective of this study is to assess the safety and tolerability of YH14618 during 24 weeks of follow-up period after single administration in patients with degenerative disc disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have signed a written informed consent voluntarily, prior to the any procedure
- •Degenerative disc disease patients of aged over 20 years
- •Have one or more of the symptomatic lumbar level(L1~S1) as confirmed using radiology(X-ray, MRI and/or discogram/CT)
- •Have been diagnosed 2~3 degree of MRI index by modified thompson classification
- •Oswestry diability index(ODI) of 30 or greater
- •Visual analog scale(VAS) of 4 or greater
排除标准
- •Subjects unable to have radiological examination
- •Have history of neurological disease, herniated lumbar disc, compression fractures and lumbar spinal surgery
- •Sacroiliac joint dysfunction
- •Have been treated with any drugs for pain control within 7 days prior to the first administration
- •Hypersensitivity to drugs
- •Pregnant women, nursing mothers or subjects who do not agree to assigned contraception in the study
- •Participated in any other clinical trials within 30 days prior to the first administration
研究组 & 干预措施
Group A
Experimental
干预措施: YH14618 (Drug)
Group B
Experimental
干预措施: YH14618 (Drug)
Group C
Experimental
干预措施: YH14618 (Drug)
Group D
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Evaulate the safety and tolerability after single intradiscal administation
时间窗: 12 weeks of observational period
Safety outcomes * Adverse events * 12-lead EKG * Physical examination * Standard lab results(hematology, blood chemistry, coagulation, urinalysis etc.)
次要结局
- Change from oswestry diability index(ODI) at week 12(Baseline, Week 12)
- Change from baseline in visual analogue scale(VAS) at week 12(Baseline, Week 12)
- Change from baseline in disc height index at 12 week(Baseline, Week 12)
- Change from baseline in magnetic resonance imaging(MRI) index(Baseline, Week 12)
研究者
研究点 (1)
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