NCT00286065已完成2 期
Multi-Centre Placebo-Controlled Randomized 2 Part Study to Determine Efficacy and Safety of Inhaled AeroLEF in the Treatment of Acute Post-Op Pain in Adult Patients Undergoing Elective Orthopedic Surgery
YM BioSciences1 个研究点 分布在 1 个国家目标入组 123 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- - Summed Pain Relief plus Pain Intensity Difference (SPRID) scores during the interval from Baseline post-surgery to 4 hours after the initial dose following surgery
研究概览
简要总结
The purpose of this study is to determine the effect of pain relief with AeroLEF in adult patients, following orthopedic surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female 18 to 70 years
- •patient alert and capable of self-administering an opioid anaglesic
- •Patient is scheduled for orthopedic surgery under general anesthesia
- •Patient has normal laboratory values
- •Physical examination with no clincially relevant findings
- •Patient in general good health based on medical history and clincially acceptable
- •Patient is able to understand the requirements of the study
- •Patient is able to communicate effectively with study personnel _Patient voluntarily gives written approval.
排除标准
- •During Part 2 (randomized period) which involves the use of placebo, patients who are undergoing a major orthopedic procedure that normally requires multimodal analgesia to achieve adequate postoperative pain control (e.g. major spine surgery, total knee arthoplasty) will be excluded.
- •Patient is taking opioid or non-opioid analgesics on a chronic basis at doses which in the opinion of the investigator would interfere with evaluations of post-operative fentanyl efficacy.
- •History of pulmonary, cardiovascular, neurologic, endocrine, hepatic, gastrointestinal (GI), or kidney disease or therapy that would jeopardize the patient's well-being by participation in this study.
- •Patient has documented or self-reported medical history of sleep apnea.
- •Patient has a documented hypersensitivity to fentanyl or other opioid analgesics.
- •Patient has a documented hypersensitivity/allergy to the components of the liposomes used in the AeroLEF formulation, including hypersensitivity to soya lecithin or related food products such as soya bean and peanut.
- •Patient is currently receiving treatment, or has received treatment in the previous two weeks, with monoamine oxidase inhibitors.
- •Patient has a history of malignancy within the past 5 years, with the exception of successfully treated non?metastatic basal cell or squamous cell carcinomas of the skin and/or localized carcinoma in situ of the cervix.
- •Patient was dosed with another investigational drug within 30 days prior to the Screening Visit.
- •Patient has current therapy with CNS-depressant medications (other than stable doses of analgesics and drugs used with surgical anesthesia).
- •Patient has current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).
- •Patient has a history of abuse of licit or illicit drug substances.
- •Patient, who in the opinion of the Investigator, is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments.
结局指标
主要结局
- Summed Pain Relief plus Pain Intensity Difference (SPRID) scores during the interval from Baseline post-surgery to 4 hours after the initial dose following surgery
次要结局
- Sum of the Pain Intensity Difference scores (SPID) for 4 hours after the start of the initial dose
- Sum of the Pain Relief scores (TOTPAR) for the 4 hours following the start of the initial dose
- Total use of rescue analgesic drug.
- Time to effective pain relief (measured by stopwatch).
- Duration of effective pain relief as measured by the interval between time to onset of effective pain relief and time to first use of rescue drug (both measured by stopwatch) or next dose of study drug.
- Clinician Global Impression (CGI) scores at 4 and 12 hours after the start of the initial post-surgery dose of study drug.
- Patient Treatment Satisfaction Rating scores at 4 and 12 hours after the start of the initial post-surgery dose of study drug.
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis PatientsCystic FibrosisNCT01746095Savara Inc.87
已完成
2 期
Phase II Study of Inhaled AeroLEF for Analgesia After ACL Knee SurgeryPainPost Operative PainNCT00791804YM BioSciences19
已完成
2 期
A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With OsteoarthritisPainNCT00404183Abbott120
已完成
3 期
A Study of Extended-Release Hydrocodone/Acetaminophen (Vicodin CR®) in Subjects With Acute Pain Following BunionectomyPainNCT00402792Abbott150
已完成
3 期
Study to Assess the Efficacy, Safety, and Tolerability of Intravitreal Aflibercept Compared to Laser Photocoagulation in Patients With Retinopathy of PrematurityRetinopathy of PrematurityNCT04101721Regeneron Pharmaceuticals127