A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of LTG-001 for Acute Pain After an Abdominoplasty
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 343
- 试验地点
- 5
- 主要终点
- SPIDr0-48
研究概览
简要总结
The goal of this clinical trial is to learn if LTG-001 works to treat post-operative / acute pain after an abdominoplasty procedure. It will also learn more information on the safety of LTG-001.
The main questions it aims to answer are:
Does drug LTG-001 treat the acute pain after surgical abdominoplasty over 48 hours? How tolerable is LTG-001 over 48 hours? What dose of LTG-001 is better for treating post-operative / acute pain?
Participants will:
Take LTG-001 bid after the surgical abdominoplasty. Remain at the clinic for approximately 48 hours during study dosing and return after two weeks for a safety check up. Report the pain relief during the 48 hours to record changes in the post-operative pain.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is male or female aged 18 to 50 years
- •Scheduled to undergo an elective "partial" abdominoplasty under general anesthesia
- •Has a body BMI 18.0 to 35 kg/m2
- •Has signed informed consent and will comply with the requirements and restrictions of the study
- •Meet lifestyle, medication, or other study restrictions
- •Subject must agree to study required use of birth control
- •Post-surgical (abdominoplasty) pain must meet the study threshold
排除标准
- •Inability to take oral medications
- •Prior abdominoplasty or a prior intra-abdominal and/or pelvic surgery (including hysterectomy and Cesarean section) that resulted in any complications
- •History of impaired hepatic function or heart disease.
- •Abnormal liver laboratories or other lab abnormality indicative of serious medical condition
- •Sensory abnormality that would confound post-surgery pain assessments
- •Chronic use of NSAIDs, benzodiazepines, opioid use within the last year, use of medications that prolong QTc intervals, or other dietary and medication restrictions
- •A subject with sleep apnea and/or on a home continuous positive airway pressure machine.
- •Positive drug screen.
研究组 & 干预措施
Placebo
干预措施: Placebo Comparator (Drug)
HB/APAP
干预措施: Active Comparator: HB/APAP (Drug)
LTG-001 High Dose
High Dose LTG-001
干预措施: Experimental: LTG-001 High Dose (Drug)
LTG-001 Low Dose
干预措施: Experimental: LTG-001 Low Dose (Drug)
结局指标
主要结局
SPIDr0-48
时间窗: 48 hours
Time-weighted SPIDr0-48 after the first dose of study drug.
次要结局
- Total Opioid Rescue(48 hours)
- No Opioid requirement(48 hours)
- Nausea and Vomiting(48 hours)
- 2-Point NPRS Reduction(48 hours)
- 1-Point NPRS Reduction(48 Hours)
- PID at 60 minutes(1 hour)
- SPID r0-24(24 hours)
- Patient Global Assessment(48 Hours)