A Phase 3, Multicenter, Randomized, Double Blind, Three-Arm Study to Evaluate the Efficacy and Safety of Tramadol Infusion (AVE-901) Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 409
- 试验地点
- 5
- 主要终点
- The Sum of Pain Intensity Differences (SPID) Through 48 Hours Post First Dose
研究概览
简要总结
The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing postoperative pain following a bunionectomy
详细描述
(Non-clinical summary)
Tramadol is a centrally-acting synthetic analgesic of the aminocyclohexanol group with opioidlike effects. Tramadol is extensively metabolized following administration, which results in a number of enantiomeric metabolites that display different opioid-receptor binding properties, and monoaminergic reuptake inhibition.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient is male or female 18-75 years of age undergoing unilateral first metatarsal bunionectomy surgery
- •Willing to give consent and able to understand the study procedures
- •Female patients must be of non-childbearing potential or be practicing a highly effective contraception
- •The patient must be willing to be housed in a healthcare facility and able to receive parenteral analgesia for at least 72 hours after surgery.
- •The patient meets definition of American Society of Anesthesiologists (ASA) Physical Class 1, or 2.
排除标准
- •Patient is not expected to receive a continuous infusion nerve block as described in the Post-Op anesthetic procedures protocol
- •Patient is undergoing bilateral or revision bunionectomy surgery
- •The patient has allergy or hypersensitivity (or is intolerant) to opioids or tramadol The patient has known physical dependence on opioids
- •The patient has taken other prior/concurrent chronic medications that have not been at a stable dose for at least 2 weeks prior to screening
- •The patient is taking herbal or dietary supplements or medications that are moderate or strong inhibitors of CYP2D6 or CYP3A4 or inducers of CYP3A4
- •The patient has taken monoamine oxidase (MAO) inhibitors, trazodone, or cyclobenzaprine within 14 days prior to surgery
- •The patient cannot be withdrawn from medications (at least 7 days prior to surgery) that may lower the seizure threshold (e.g. anti-psychotic agents, MAOI inhibitors) or which increase serotonergic tone (e.g. selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, triptans).
- •The patient has a history of epilepsy, or is known to be susceptible to seizures
- •The patient has a history of Long QT Syndrome or a relative with this condition
- •The patient has expressed suicidal ideation or is considered to be at risk of suicide.
- •The patient is morbidly obese (body mass index [BMI] ≥ 40 kg/m2) or has documented sleep apnea requiring pharmacological or device intervention.
- •Clinically significant abnormalities in the judgement of the Investigator
- •The patient was administered an investigational product within 30 days prior to Screening.
- •The patient has previously participated in a clinical study with AVE-901.
研究组 & 干预措施
AVE-901 50 mg
干预措施: Tramadol (Drug)
AVE-901 25 mg
干预措施: Tramadol (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
The Sum of Pain Intensity Differences (SPID) Through 48 Hours Post First Dose
时间窗: 48 hours post first dose
Pain intensity was recorded using the Numerical Pain Rating Scale (NPRS) from 0 to 10, where 0 was no pain and 10 was the worst pain imaginable at hrs: .5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, 36, 38, 40, 42, 44, 46, 48. As higher pain scores indicate worse pain, a negative Pain Intensity Difference (PID) indicates less pain (improvement from baseline). Thus, SPID scores are expected to be negative if a patient's pain decreases over time, with the lower SPID values indicating greater reduction in pain intensity.
次要结局
未报告次要终点