Analgesic Efficacy and Pharmacokinetic-pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 After Impacted Mandibular Third Molar Extraction - A Double-blind, Randomised, Placebo-controlled Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Sum of pain intensity differences at 55 min
研究概览
简要总结
A randomised, double-blind, parallel-group, study comparing the analgesic effect of intranasal CT001 to intranasal sufentanil, intranasal ketamine or placebo for treatment of acute pain in adults undergoing surgical removal of an impacted mandibular third molar, where bone removal is judged to be needed.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy (The American Society of Anaesthesiologists' Physical Classification System (ASA) I-II) male or female participants scheduled for surgical removal of an impacted mandibular third molar, where bone removal is judged to be needed
- •Age: ≥ 18 and < 56 years
- •Body Mass index above (>)18.5 or below (<) 30.0 kg/m2
- •Prior to randomisation: Numeric Pain Rating Scale (NRS anchored by 0 = "no pain", 10 = "worst pain imaginable") ≥ 5 at rest within 4 hours after the administration of the last dose of local anaesthetic
排除标准
- •Current or history of any clinically significant disease or disorder, which, in the opinion of the investigator, may put the potential subject at risk when participating in the study, or influence the potential subject's ability to participate in the study or influence the study results.
- •Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the administration of investigational product that is likely to introduce additional risk factors, jeopardize study integrity, or to interfere with the study assessments or procedure
- •History of increased bleeding tendency
- •Clinically significant mental illness
- •Opioid Risk Tool score of >3
- •Pain Catastrophizing Scale score, total points >30
- •Hospital Anxiety and Depression Scale (HADS), points ≥ 11 for anxiety or ≥ 11 points for depression
- •Daily intake of analgesics
- •History of alcohol or drug abuse or use of illicit drugs or positive screen for drugs of abuse at screening or on admission to the Clinic prior to the administration of the investigational product.
- •Abnormal nasal cavity/airway
研究组 & 干预措施
Sufentanil 40 mcg/Ketamine 40 mg
干预措施: Sufentanil (Drug)
CT001
干预措施: CT001 (Drug)
Placebo
干预措施: Placebo (Drug)
Sufentanil 27 mcg
干预措施: Sufentanil (Drug)
Ketamine 27 mg
干预措施: Ketamine (Drug)
Sufentanil 13 mcg
干预措施: Sufentanil (Drug)
Ketamine 13 mg
干预措施: Ketamine (Drug)
Sufentanil 40 mcg
干预措施: Sufentanil (Drug)
Ketamine 40 mg
干预措施: Ketamine (Drug)
Sufentanil 13 mcg/Ketamine 13 mg
干预措施: Sufentanil (Drug)
Sufentanil 13 mcg/Ketamine 13 mg
干预措施: Ketamine (Drug)
Sufentanil 13 mcg/Ketamine 27 mg
干预措施: Sufentanil (Drug)
Sufentanil 13 mcg/Ketamine 27 mg
干预措施: Ketamine (Drug)
Sufentanil 13 mcg/Ketamine 40 mg
干预措施: Sufentanil (Drug)
Sufentanil 13 mcg/Ketamine 40 mg
干预措施: Ketamine (Drug)
Sufentanil 27 mcg/Ketamine 13 mg
干预措施: Sufentanil (Drug)
Sufentanil 27 mcg/Ketamine 13 mg
干预措施: Ketamine (Drug)
Sufentanil 27 mcg/Ketamine 40 mg
干预措施: Sufentanil (Drug)
Sufentanil 27 mcg/Ketamine 40 mg
干预措施: Ketamine (Drug)
Sufentanil 40 mcg/Ketamine 13 mg
干预措施: Sufentanil (Drug)
Sufentanil 40 mcg/Ketamine 13 mg
干预措施: Ketamine (Drug)
Sufentanil 40 mcg/Ketamine 27 mg
干预措施: Sufentanil (Drug)
Sufentanil 40 mcg/Ketamine 27 mg
干预措施: Ketamine (Drug)
Sufentanil 40 mcg/Ketamine 40 mg
干预措施: Ketamine (Drug)
结局指标
主要结局
Sum of pain intensity differences at 55 min
时间窗: 0-55 min
Derived from pain intensity scores measured by the Numerical Rating Scale (0-10, 0= no pain, 10= worst possible pain).
PK-PD relationship for analgesic efficacy IN sufentanil, IN ketamine and IN CT001
时间窗: 0-180 min
To assess the relationship between analgesic efficacy and the plasma concentrations of intranasal sufentanil, intranasal ketamine and intranasal CT001.
次要结局
- Time to meaningful pain relief(0-180 min)
- Maximum Pain intensity difference (PIDmax)(0-180 min)
- Time to rescue medication(0-180 min)
- Sum of pain intensity differences at 30 min(0-30 min)
- Mean pain intensity difference (PID) from baseline at rest(0-180 min)
- Median time to a request for rescue medication(0-180 min)
- Rescue medication(0-180 min)
- Sum of pain intensity differences at 90 min(0-90 min)
- Time to perceptible pain relief(0-180 min)
- Number of patients who are considered a responder/non-responder, 30%(0-30 min)
- Number of patients who are considered a responder/non-responder, 50%(0-30 min)
- Ramsay sedation score(0-179 min)
- Mean pain intensity difference (PID) from baseline on jaw movement(0-181 min)