A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Active Comparator Study of Hydrocodone Bitartrate Extended Release (HC-ER) in Adults Following Bunionectomy Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 241
- 主要终点
- The Sum of Pain Intensity Differences (SPID) for the Visual Analog Scale Pain Intensity (VASPI)
研究概览
简要总结
The purpose of the study is to establish a dose-response relationship among several capsule strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to placebo following bunionectomy surgery
详细描述
Sum of Pain Intensity Differences (SPID) for the Primary pain measurement: VASPI (Visual Analog Scale of Pain Intensity) from time 0 to 12 hrs; Safety evaluations assessed: laboratory evaluations, physical examinations, vital signs/pulse oximetry and electrocardiography
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Subject was able to read and voluntarily sign the Institutional Review Board (IRB) approved, written informed consent document and given the opportunity to ask questions regarding the study prior to the performance of any study- specific procedures.
- •Subject required primary unilateral first metatarsal bunionectomy surgery with or without hammertoe repair with no other collateral procedures allowed
- •Subject was male or female at least 18 years of age.
- •Subject weighed > or = 100 lbs (pounds).
- •Subject was willing and able to comply with the protocol and able to score their pain intensity.
- •Subject was in good health as determined by the investigator on the basis of medical history, physical examination, Electrocardiogram (ECG) and screening laboratory results.
- •Subject had not developed a condition or complications as result of the bunionectomy procedure that would preclude their participation in the study.
- •Subject was willing and able to remain at the recovery day care center for the entire 24-hour Treatment period.
排除标准
- •Subject was pregnant or lactating.
- •Subject had been on an investigational drug within 30 days prior to the initiation of study drug.
- •Subject had donated blood or blood components within one month prior to study (Check-in).
- •Subject had a know allergy or hypersensitivity to opioids, acetaminophen, and/or ketorolac.
- •Subject had a known history of substance or alcohol abuse within 2 years prior to Screening.
- •Subject tested positive to drug screens (cocaine, marijuana, opioids, benzodiazepines, and barbiturates) that could not be justified by prescription use.
- •Subject had a condition that would contraindicate the use of opioid analgesia (e.g., pulmonary disease or paralytic ileus).
- •Subject had received a selective serotonin reuptake inhibitor (SSRI), monoamine oxidase inhibitor (MAOI) carbamazepine, quinidine, and/or tricyclic antidepressants (TCA) compounds within 1-month prior to Check-in.
- •Subject had received opioids, tranquilizers, sedatives, or hypnotics within 48 hours prior to Check-in.
- •Subject had received corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or other analgesics within 24 hours prior to Check-in.
研究组 & 干预措施
10 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 10 mg
干预措施: 10 mg HC-ER (Drug)
20 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 20 mg
干预措施: 20 mg HC-ER (Drug)
30 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 30 mg
干预措施: 30 mg HC-ER (Drug)
40 mg HC-ER
Hydrocodone bitartrate extended release (HC-ER) 40 mg
干预措施: 40 mg HC-ER (Drug)
10 mg HC / 325 mg APAP
10 mg Hydrocodone (HC) / 325 mg acetaminophen (APAP)
干预措施: 10 mg HC / 325 mg APAP (Drug)
Placebo
Matching placebo
干预措施: Matching Placebo (Drug)
结局指标
主要结局
The Sum of Pain Intensity Differences (SPID) for the Visual Analog Scale Pain Intensity (VASPI)
时间窗: 0-12 hours
次要结局
未报告次要终点