A Phase III, Randomized, Double-blind, Placebo-controlled, Multicenter, Repeat-dose Study of the Safety and Efficacy of Acuroc Tablets Following Bunionectomy Surgery in Adult Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 405
- 主要终点
- SPID48
研究概览
简要总结
The purpose of this study is to determine whether oxycodone HCl and niacin are effective in the treatment of pain following bunionectomy surgery.
详细描述
This was a Phase III, randomized, double blind, placebo controlled, multicenter, repeat dose study of the safety and efficacy of 2 dose levels of Acurox™ Tablets versus placebo for the treatment of moderate to severe postoperative pain following bunionectomy surgery.
Patients underwent a primary unilateral first metatarsal bunionectomy with or without ipsilateral hammer toe repair during standardized local anesthesia with intravenous (IV) sedation. Eligible patients who reported moderate or severe pain within 6 hours after surgery entered the Treatment Phase and were randomized to 1 of 3 double blind treatments: placebo tablets or 1 of 2 dose levels of Acurox™ Tablets (ocyxcodone HCl/niacin). The Treatment Phase continued with study medication every 6 hours (irrespective of rescue medication use) for 48 hours (8 doses of study medication). Toradol (ketorolac tromethamine) was available as a rescue medication upon request.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Patient is male or female at least 18 years of age
- •For women of child-bearing potential: woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
- •Patient is scheduled to have a bunionectomy
- •Patient must be willing to stay at the study site for at least 48 hours from the initial dose of study medication post-surgery
排除标准
- •Patient has a current disease or history of a disease that will impact the study or the patient's well-being
- •Patient has used or intends to use any of the medications that are prohibited by the protocol
- •Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen
- •Patient is hypersensitive to any of the medications to be used in the study
- •Patient has taken another investigational drug within 30 days prior to Screening
研究组 & 干预措施
Acurox 7.5/30
Oxycodone HCl 7.5mg/Niacin 30mg tablet
干预措施: Acurox 7.5/30 (Drug)
Placebo
Tablet
干预措施: Placebo (Drug)
Acurox 5/30mg
Oxycodone HCl 5mg/Niacin 30mg tablet
干预措施: Acurox 5/30 mg (Drug)
结局指标
主要结局
SPID48
时间窗: 48 hours
Time weighted Sum of Pain Intensity Differences over the first 48 hours (SPID48) is the sum of the Pain Intensity Difference (PID) scores observed at 0.5 , 1, 2, 3, 4, 5, 6, 12, 18, 24, 30, 36, 42, and 48 hours post-dose. Pain Intensity scores at each timepoint are based on a 100 mm visual analog scale (VAS) from 0 = no pain to 100 = worst pain imaginable. PID is calculated as the timepoint score less the baseline pre-dose score (i.e. PID.5 = PI.5 - PI0). SPID48 = the PID for each timepoint multiplied by a time weighting factor; which is the difference (in hours) between the PID observation and prior observation. SPID48 = PID.5\*.5 + PID1\*.5 + PID2\*1 + PID3\*1 + PID4\*1 + PID6\*2 +PID12\*6 + PID18\*6 +PID24\*6 + PID30\*6 + PID36\*6 + PID42\*6 + PID48\*6. The maximum SPID48 value is 4,800 (assumes PI0 of 100 and a PI of 0 at all subsequent timepoints) with a midpoint SPID48 of 2,400 (PI0=50 and PI of 0 at all subsequent readings).
次要结局
未报告次要终点