An International, Randomised, Double Blinded, Multi-centre, Active- and Placebo-controlled Dose Response Trial to Evaluate the Efficacy and Safety of SABER-Bupivacaine for Postoperative Pain Control in Patients Undergoing Primary, Elective, Open, Abdominal Hysterectomy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Durect
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Pain Intensity (PI)
研究概览
简要总结
The objective is to identify the optimal dose of SABER-Bupivacaine for postoperative pain control in patients undergoing hysterectomy on the basis of pharmacokinetics, efficacy and safety evaluations. The study duration consists of a screening period up to 14 days and a treatment period 14 days with a long term follow up visit at 6 months. The study will provide further data on the efficacy and safety of the product.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •A planned elective, abdominal hysterectomy
- •Patients suitable for general anaesthesia
排除标准
- •Known clinically significant hepatic, gastrointestinal, renal, haematological, urologic, neurological, respiratory, endocrine or cardiovascular system abnormalities
- •Known serious uncontrolled illness: cancer, psychiatric or metabolic disturbances. History of cured localised malignancies is allowed (i.e. basal or squamous cell skin carcinoma, breast carcinoma or cervical carcinoma)
- •Abnormal ECG
- •Prolonged QT syndrome
- •Current or regular use of analgesic medication for other indication(s)
研究组 & 干预措施
SABER-Bupivacaine Treatment 1a
double-blind
干预措施: SABER-Bupivacaine Treatment 1a (Drug)
Placebo SABER-Bupivacaine Treatment 1b
double-blind
干预措施: Placebo SABER-Bupivacaine Treatment 1b (Drug)
Bupivacaine HCl Treatment 1c
double-blind
干预措施: Bupivacaine HCl Treatment 1c (Drug)
SABER-Bupivacaine Treatment 2a
double-blind
干预措施: SABER-Bupivacaine Treatment 2a (Drug)
Placebo SABER-Bupivacaine Treatment 2b
double-blind
干预措施: Placebo SABER-Bupivacaine Treatment 2b (Drug)
Bupivacaine HCl Treatment 2c
double-blind
干预措施: Bupivacaine HCl Treatment 2c (Drug)
结局指标
主要结局
Pain Intensity (PI)
时间窗: 1 to 72 hours post-surgery
Pain intensity (PI) on movement AUC over the period 1 to 72 hours post-surgery. Subjects assessed their pain intensity using an 11-point Pain Intensity Numeric Rating Scale (PI-NRS) with NRS scores ranging from 0 (no pain) to 10 (worst pain possible). The AUC is computed for each patient using the standard trapezoidal rule and normalised by dividing by the time interval over which it is computed. This normalisation converts the AUC to the natural pain scale (NRS 0-10) to allow for better translation of the clinical treatment effect magnitude.
Supplemental Opioid Use
时间窗: 0-3 days after surgery
Cumulative IV morphine-equivalent dose of opioid rescue medication
次要结局
- Time to First Opioid Rescue Medication Usage(0-14 days after surgery)
- Opioid Related Side Effects(0-7 days after surgery)