NCT00791804已完成2 期
A Phase II Study Evaluating Inhaled AeroLEF(Liposome-Encapsulated Fentanyl 500mcg/mL)for Post-Operative Pain in Adults After ACL Knee Surgery.
YM BioSciences2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2004年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF
研究概览
简要总结
To evaluate the safety and efficacy of self-titration to effective analgesia with inhaled AeroLEF in patients with moderate/severe acute pain in the post-surgical setting.
详细描述
After elective ACL knee surgery, consented patients will receive a single dose of AeroLEF for moderate/severe acute pain. Patients stop dosing if they achieve analgesia, complete the maximum available dose, or experience dose-limiting side effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female between ages 18 years and 60 years.
- •A body mass index of between 18 and 30, inclusive.
- •If a female of child-bearing potential, the patient must have a negative urine pregnancy test at screening and baseline.
- •Scheduled for elective ACL arthroscopic knee repair surgery, and meet the criteria of the American Society of Anesthesiologists [ASA] Physical Status Criteria of Class I or Class II, and suitability for an anesthetic plan limited to general anesthesia (inhalation/IV) with post-operative PCA initiated in a PACU setting and not requiring CPM before the 12 hours post surgery observation is completed.
- •Scheduled for a morning surgery and anticipating remaining in the hospital for an overnight stay.
- •Normal laboratory values for clinical chemistry, haematology and urinalysis. If a patient has abnormal clinically significant laboratory values, inclusion will be permitted at the discretion of the investigator .
- •Physical examination with no clinically relevant findings as determined by the investigator.
- •Able to demonstrate the ability to understand the requirements of the study, willingness to provide written informed consent (prior to any study-related procedures being performed) and able to adhere to the study restrictions, and return for the required assessments.
排除标准
- •History of addiction to drugs or alcohol.
- •Exposure to any investigational drug within the 30 days prior to enrolment.
- •Documented hypersensitivity to fentanyl or other opioid analgesics
- •Documented hypersensitivity/allergy to the components of the liposomes used in the AeroLEF formulation
- •History of pulmonary, cardiovascular, neurologic, endocrine, hepatic, GI, or kidney disease or therapy that would jeopardize the patient's well-being by participation in this study (excluded by ASA I and II categories)
- •Currently receiving treatment, or have received treatment in the previous two weeks, with antidepressant or antipsychotic drugs (including monoamine oxidase inhibitors).
- •Clinically significant ongoing medical conditions.
- •Currently receiving treatment for chronic pain.
- •Current therapy with narcotic or CNS-depressant medications.
- •Current chronic therapy with NSAIDs, ASA or acetaminophen within the previous 7 days.
- •Patient, who in the opinion of the investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
- •Blood donation or other blood loss within 45 days prior to enrolment in the study totalling 100 mL or greater.
研究组 & 干预措施
Single Arm
Experimental
干预措施: AeroLEF (Drug)
结局指标
主要结局
The primary efficacy variable is the time to effective analgesia following initiation of dosing with AeroLEF
时间窗: Post operative period 12 hours
次要结局
- Time to first perceptible analgesic effect(Post-operative period 12 hours)
- Time and total of first rescue analgesic(Post-operative period 12 hours)
- Duration of effective analgesia(Post-operative period 12 hours)
- Pain rating scores(Post-operative period 12 hours)
- Adverse events(Post-operative period 12 hours)
研究者
研究点 (2)
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