INcreased Flow Utilizing Subcutaneously Enabled Morphine (INFUSE-Morphine) With and Without Human Recombinant Hyaluronidase (HYLENEX) and Intravenously
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- • Determine the Tmax and other pharmacokinetic parameters of morphine injected subcutaneously with HYLENEX compared to without HYLENEX and injected intravenously
研究概览
简要总结
Double-blind study comparing the pharmacokinetics, safety and tolerability of morphine administered subcutaneously (SC) with and without human recombinant hyaluronidase (HYLENEX) and intravenously conducted in patients in a hospice care setting or through a palliative care medicine setting. In this within-patient controlled study, each eligible study patient receives a single injection by each of the three methods of morphine administration, sequentially on three consecutive days, according to the order specified by a randomization schedule.
Each of the three injections consists of 5 mg of morphine (1.0 mL of 5 mg/mL solution). The HYLENEX injection will be 1 mL of 150 units. Although the IV administration will not be blinded, the two SC injections will be double-blinded, using the same volume of normal saline (0.9% sodium chloride) placebo (1.0 mL) as HYLENEX.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 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
- •Males or females at least 18 years of age who are patients of San Diego Hospice & Palliative Care or recruited through San Diego Hospice & Palliative Care or the UCSD Center for Pain and Palliative Medicine.
- •During the treatment days of the study, on opioid therapy other than morphine that is equivalent to ≥ 60 mg oral morphine per day and without unacceptable toxicity.
- •Vital signs (BP, HR, RR) within normal range.
- •Adequate venous access in both upper extremities.
- •A negative pregnancy test (if female of child-bearing potential) within 7 days prior to first injection.
- •Life expectancy ≥ ten days.
- •Decision-making capacity.
- •Signed, written IRB-approved informed consent. -
排除标准
- •Known hypersensitivity or history of any toxicity to morphine.
- •Morphine within the 4 days prior to the first study medication injection or anticipated to be receiving morphine during any of the treatment days in this study.
- •Any contraindication to morphine.
- •Known hypersensitivity to naloxone.
- •Known allergy to hyaluronidase or any other ingredient in the formulation of HYLENEX.
- •Known allergy to bee or vespid venom.
- •Contraindication to IV heparin lock or known hypersensitivity to heparin.
- •Edema, infection, or any other lower extremity or pelvic disorder that might affect subcutaneous absorption from the thigh.
- •Hemoglobin < 10 g/dL.
- •Presence of any other medical condition that would present an unacceptable safety risk to the patient.
- •Participation in a study of any investigational drug or device within 30 days of enrollment in this study.
研究组 & 干预措施
2
SC Morphine with Hylenex
干预措施: Hylenex (Drug)
3
SC Morphine with Saline
干预措施: Hylenex (Drug)
结局指标
主要结局
• Determine the Tmax and other pharmacokinetic parameters of morphine injected subcutaneously with HYLENEX compared to without HYLENEX and injected intravenously
时间窗: 29 days
次要结局
- Compare the safety and tolerability of these three methods of injections of morphine(29 days)