A Phase 3, Open-Label, Single-Arm Study To Assess The Safety Of Hydromorphone Hydrochloride Delivered By Intrathecal Administration
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 364
- 试验地点
- 1
- 主要终点
- Granulomas
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of hydromorphone hydrochloride administered by intrathecal delivery.
详细描述
This is an open-label, single-arm safety study to evaluate the safety of hydromorphone hydrochloride given by continuous intrathecal infusion using an implantable pump device. This study will enroll both subjects on a current opioid intrathecal medication as well as naïve subjects now current on intrathecal opioid medications. All subjects currently on intrathecal opioid treatment will be converted from their current intrathecal therapy to intrathecal hydromorphone hydrochloride according to standard medical practice. After an optimal dose for pain relief is achieved, subjects will remain on therapy for a total of 12 months or until discontinuation from the study. During this continuous dosing period, dose adjustments (up or down) are permitted to manage pain or side effects provided a maximum dose of 10 mg/day is not exceeded. Subjects will be assessed for pain intensity using a visual analog scale of pain intensity (VASPI) instrument at each study visit.
Subjects will be evaluated for side effects and clinical complications associated with the use of intrathecal hydromorphone. Events will be classified by intrathecal drugs used and concentrations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must meet all of the following criteria to be included:
- •Subjects must be at least 18 years of age and no more than 75 years old.
- •Clinically diagnosed with severe chronic pain for at least a 6-month period.
- •Subject is reasonably expected to benefit from intrathecal pain medication and has a programmable implantable intrathecal pump or meets clinical criteria for implantation of an intrathecal pump per Standard of Care.
- •Subject agrees to sign a Pain Treatment Agreement (Narcotic Contract) limiting narcotic prescriptions to the study medication prescribed by the investigator.
- •Subject must be cognitively intact and, in the opinion of the investigator, capable of participation in the trial.
- •Female subjects of child-bearing potential must agree to use a medically acceptable and effective double-barrier method of birth control.
- •Subjects who can receive an MRI if required by the study protocol.
- •Provides written Ethics Committee approved informed consent.
- •Willing to comply with all study procedures and requirements.
排除标准
- •Subjects meeting any of the following criteria will be excluded:
- •Women who are pregnant or breast-feeding.
- •Subject has any known or suspected allergy to hydromorphone hydrochloride or to the materials of the infusion pump or intrathecal catheter.
- •Subject has a history of dependence and abuse of opioids, stimulants, alcohol, or benzodiazepines, as defined by Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria, within the past year (physical dependence on prescribed opioid analgesics is allowed but abuse of opioids according to DSM-IV is not permitted, i.e. opioid addiction for recreational use).
- •Subjects who show signs of active systemic infection.
- •Subjects with a metastatic cancer to the spinal canal or a known central nervous system contraindication to intrathecal therapy.
- •Subjects have a condition requiring diathermy procedures.
- •Subject has a life expectancy of less than 12 months.
- •Subjects who are unable or unwilling to return to all of the required follow-up visits.
- •As a result of medical review and physical examination, the Investigator considers the subject unfit for the study.
研究组 & 干预措施
Hydromorphone Hydrochloride
Hydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation
干预措施: Hydromorphone Hydrochloride (Drug)
Hydromorphone Hydrochloride
Hydromorphone hydrochloride for intrathecal administration, 12 months safety evaluation
干预措施: Programmable Implantable pump (Device)
结局指标
主要结局
Granulomas
时间窗: 12 months
Subjects with Clinical Signs and Symptoms of Granuloma \[Note: The primary endpoint of this trial is Safety. There is no formal efficacy assessment planned in this open-label safety study.\]
次要结局
- Visual Analog Scale Pain Intensity (VASPI)(Early Termination/Final Visit through 12 months)
- Patient Global Impression of Change (PGIC)(Early Termination/Final Visit through 12 months)
- Brief Pain Inventory (BPI) - Mean Pain Severity(Early Termination/Final Visit through 12 months)