NCT04096391已完成不适用
Post-market, Randomized, Controlled, Prospective Study Evaluating Intrathecal Pain Medication (IT) Versus Conventional Medical Management (CMM) in the Non-cancer, Refractory, Chronic Pain Population (PROSPER)
Evolve Restorative Center1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2019年6月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Compare the change in Numeric Pain Rating Scale between the IDDS group and the CMM group
研究概览
简要总结
This study is being conducted to compare intrathecal morphine using the commercially available intrathecal drug delivery systems (IDDS), and conventional medical management (CMM) in subjects with non-cancer, refractory chronic pain.
详细描述
This study will evaluate the following objectives:
Primary objective:
- To compare the change in pain intensity from baseline based on the Numeric Rating Scale [NRS] between subjects randomized to the IDDS group and subjects randomized to the CMM group.The comparison will be conducted at 3, 6, 9 and 12 months following enrollment. The evaluation at 6 months will be considered the primary time point for evaluation.
Secondary objectives:
For each of the following secondary objectives, the comparisons between the IDDS group and CMM group will be made using the intra-subject change from baseline as the dependent variable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must have signed and dated the IRB approved Informed Consent Form and HIPAA Authorization prior to any study procedures being performed
- •Subject must be willing and able to complete study requirements including diaries, questionnaires and attend all visits, in the opinion of the investigator
- •Subject must be male or female and at least 22 years of age
- •Subjects who are female are non-lactating and if of childbearing potential have a negative urine pregnancy test at screening
- •Subjects who are currently be receiving ≤ 90 mg/day morphine per day dose (or MME), with stable dose at equivalent of systemic opioids at Screening
- •Subjects who are on a stable dose of opioids (no change in type or prescribed frequency or dose) for 30 days prior to the screening as documented in medical history;
- •Subjects who have refractory pain despite failure of regional minimally invasive treatment options, including epidurals, facets, rhizotomies, direct or indirect spinal stenosis treatments, etc.
- •Subjects who are a new candidate for chronic intrathecal drug therapy (including no prior intrathecal/epidural trial for pump infusion therapy)
- •Subjects have not been implanted with a spinal cord stimulator for pain
- •Subjects currently do not have an implanted spinal cord stimulator for pain
- •Subjects who have a diagnosis of nonmalignant, chronic intractable pain as documented in the medical history
- •Subjects who are medically stable and able to undergo surgery for implantation of the Prometra® II Infusion System
- •Subject must have completed a psychological evaluation within 6 months prior to Screening
- •Subject must complete an intrathecal trial resulting in candidacy for pump implantation during Screening
排除标准
- •A potential subject who has any contraindications listed in the Prometra® II labeling or any contraindications of intrathecal agents employed in the United States within the PACC, will be excluded. All subjects meeting any of the following criteria will also be excluded from this study:
- •Subjects currently have a spinal cord stimulator implanted for pain
- •Subjects previously had a spinal cord stimulator implanted for pain
- •Subjects who have psychological or other health conditions, financial, and/or legal concerns (within 3 months prior to Screening) that would interfere with the subject's ability to fulfill the requirements of the protocol as per the investigator's opinion
- •Subjects who have a history of alcohol abuse or illicit drug use within 2 years of screening
- •Subjects who have an active malignancy or has been diagnosed with cancer and has not been in remission for at least 1 year prior to Screening
- •Subjects who are female and who are pregnant, nursing or planning a pregnancy during the study or females of childbearing potential who are unable or unwilling to use a form of contraception during the study.
- •Subjects who plan to enroll or is currently enrolled in another investigational drug or investigational medical device study or has participated in an investigational drug or medical device study within 30 days prior to Screening
- •Subject has any condition or situation which, in the investigator's opinion, puts the patient at significant risk, could confound the study results, or may interfere significantly with the subject's participation in the study
- •At the Baseline Visit or prior to Randomization, a subject will be excluded from continued participation if the subject has:
- •Subjects that have a mean of the reported 12 hour "average" NPRS responses of < 6 on an eleven-point scale (0 to10) rated over the 5 days prior to the Baseline Visit (as recorded in the electronic Study Diary) in the absence of intolerable side effects as documented in the medical history
- •Subjects with a negative urine test for opioids at Baseline
- •Subjects with a positive Pregnancy test, if applicable
- •Subjects that failed the intrathecal trial during Screening
研究组 & 干预措施
Intrathecal Drug Delivery System
Active Comparator
Subjects randomized to the Intrathecal Drug Delivery System group will be implanted with the Prometra System under sterile technique in accordance with the Instructions for Use. The pump will be filled at the time of implantation with the prescribed medication.
干预措施: Flowonix Prometra® II Programmable Infusion System (Device)
Conventional Medical Management
Active Comparator
Subjects randomized to the Conventional Medical Management group will continue with the standard of care procedures.
干预措施: Pain Medicine (Drug)
结局指标
主要结局
Compare the change in Numeric Pain Rating Scale between the IDDS group and the CMM group
时间窗: Comparisons will be done prior to baseline visit and at 3, 6, 9 and 12 month visits.
The Numeric Pain Rating Scale (NPRS) is a 0-10 numeric pain rating scale (11 point scale), where a higher scores equates to more pain. The primary endpoint for this post-marketing study is the comparison of the NPRS between the IDDS group and the CMM group collected in the Study Diary at various time points.
次要结局
- Compare the change in PROMIS 29 scores between the IDDS group and CMM group(Individual subject scores recorded at baseline visit and at 3, 6, 9 and 12 month visits.)
- Comparison of other concurrent treatments(Individual subject counts recorded at 3, 6, 9 and 12 month visits will be compared.)
- Comparison of the accrued cost of therapy for pain(Cost of therapy will be obtained at 3, 6, 9 and 12 month visits.)
研究者
研究点 (1)
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