A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Evaluating the Efficacy and Safety of LTG 001 for Acute Pain After Surgical Removal of Impacted Third Molars
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- SPID 0-12
研究概览
简要总结
The goal of this clinical trial is to learn if LTG-001 works to treat pain after third molar removal surgery in adults. It will also learn about the safety of LTG-001. The main questions it aims to answer are:
Does drug LTG-001 treat the acute pain after surgical removal of impacted third molars (wisdom teeth) over 12 hours? How tolerable is LTG-001 after surgical removal of impacted third molars (wisdom teeth) over 12 hours?
Researchers in Part 1 will compare drug LTG-001 to a placebo (a look-alike substance that contains no drug) and in Part 2 to a placebo and a comparator to see if drug LTG-001 treats the post-surgical pain.
Participants will:
Take LTG-001 one time after the surgical removal of impacted third molars. Remain at the clinic for 12 hours after study dosing and return after a week for a safety check up.
Report the pain relief during the 12 hours after dosing 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 50 Years（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, inclusive, at the time of signing the informed consent
- •Has a body weight ≥ 45 kg and a BMI ≤ 35 kg/m
- •Subject requires extraction of 2 or more third molars, two of which must be mandibular molars that must be fully or partially bony, or combination of one fully and one partially bony impaction.
- •Subject must agree to study required use of birth control.
- •Post-surgical pain must meet protocol requirements.
排除标准
- •Inability to take oral medications
- •Prior dental surgery within 60 days or other surgical history that could confound surgery or post-operative procedures.
- •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.
- •Participant is under legal custodianship.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Other)
Suzetrigine
Comparator
干预措施: Suzetrigine (Drug)
LTG-001 Mid Dose
Medium Dose
干预措施: LTG-001 Mid Dose (Drug)
LTG-001 Low Dose
Low Dose
干预措施: LTG-001 Low Dose (Drug)
LTG-001 High Dose
High Dose
干预措施: LTG-001 High Dose (Drug)
结局指标
主要结局
SPID 0-12
时间窗: 12 hours
Pain Intensity NRS Score change over the study.
次要结局
- Perceptible Pain Relief(12 hours)
- 2 Point Reduction in Pain on 0-10 Numerical Rating Scale(12 hours)
- Meaningful Pain Relief(12 hours)
- Time to Rescue(12 hours)
- Global Evaluation(12 hours)
- No Required Rescue(12 hours)
- Total Rescue(12 hours)
- TOTPAR over 0 to 12 hours(12 hours)