NCT00904085已完成3 期
A Randomized, Double-blind Evaluation of the Analgesic Efficacy and Safety of a Low Dose Oxymorphone Immediate Release in Patients Following Ambulatory Arthroscopic Knee Surgery
Endo Pharmaceuticals0 个研究点目标入组 122 人开始时间: 2003年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 主要终点
- Sum of Pain Intensity (SPID) Visual Analog Scale (VAS)
研究概览
简要总结
The purpose of this study was to compare the analgesic efficacy of 5 mg oxymorphone IR with placebo in patients with mild to moderate pain following outpatient knee arthroscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- 是
入选标准
- •Males or females, 18 years of age or older, who have completed outpatient knee arthroscopy
- •Have an initial pain intensity score of between 30mm and 70mm on a 100mm Visual Analogue Scale(VAS) and a categorical pain rating scale of none, mild, moderate, or severe,
- •Have been informed of the nature of the study and provided written informed consent
排除标准
- •Have a positive pregnancy test
- •Have received any of the following medications within 24 hours prior to dosing: COX2 inhibitors, Minor Tranquilizers, Muscle relaxants, Antihistamines
- •Long-acting oral and parenteral analgesics are prohibited for at least 12 hours prior to receiving study medication.
- •Have received any of the following medication within 48 hours prior to dosing: Chronic use of analgesics (opioid or non-opioid including aspirin [>325 mg/day], acetaminophen, and NSAIDs)
- •Have received MAOI drugs within 2 weeks prior to dosing
- •Not stabilized on the following medications for at least 4 weeks prior to dosing: Tricyclic antidepressant drugs, Serotonin reuptake inhibitors, Amphetamines used for ADHD
研究组 & 干预措施
Oxymorphone
Active Comparator
干预措施: Oxymorphone IR (Drug)
Placebo
Placebo Comparator
干预措施: Oxymorphone IR (Drug)
结局指标
主要结局
Sum of Pain Intensity (SPID) Visual Analog Scale (VAS)
时间窗: 2 months
次要结局
未报告次要终点
研究者
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