A Randomised, Double Blind, Placebo-Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1940, in Patients Undergoing Impacted Mandibular Third Molar Extraction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 151
- 试验地点
- 1
- 主要终点
- Pain Area Under the Curve 0-8h (AUC0-8h)
研究概览
简要总结
The primary aim of this study is to investigate if AZD1940 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1940 to placebo ("inactive substance") on pain. A number of patients will instead receive the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen, will be allowed if a need for additional painkillers would arise. A number of patients will receive Naproxen as control.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients scheduled for surgical removal of one partial or complete impacted mandibular third molar.
- •Provision of signed informed consent.
- •Healthy males or non-fertile females.
排除标准
- •History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
- •History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder according to the criteria in the Diagnostic and Statistical Manual of Mental Disorder, 4th edition.
研究组 & 干预措施
AZD1940
AZD1940 800ug given predose
干预措施: AZD1940 (Drug)
Naproxen
Naproxen 500mg given pre-surgery
干预措施: Naproxen (Drug)
Placebo
Placebo given pre-surgery
干预措施: Placebo (Drug)
结局指标
主要结局
Pain Area Under the Curve 0-8h (AUC0-8h)
时间窗: 0-8 h(from end of surgery to 8 hours post surgery)
Area under the Visual Analogue Scale (VAS, 0-100 mm) time curve 0-8h (from end of surgery). Missing values in the pain-by-time curve was imputated using linear interpolation, last observation carried forward (LOCF) or first observation carried backwards (FOCB) as applicable.
次要结局
- Pain Area Under the VAS Versus Time Curve 0-4h (AUC0-4h)(0-4h (from end of surgery to 4 hours post surgery))
- Maximum Pain Based on VAS Scale(From end of surgery to 8h or time first intake of rescue medication (whichever came first))
- Mean Pain Based on a VAS Scale(From end of surgery to 8h or time to first intake of rescue medication (whichever came first))
- Pain at Jaw Movement AUC0-8h(0-8h from end of surgery to 8 hours post surgery)
- Pain at Jaw Movement AUC0-4h(0-4h after end of surgery to 4 hours post surgery)
- Maximum Pain at Jaw Movement(From end of surgery to 8h or time to first intake of rescue medication (whichever came first))
- Mean Pain at Jaw Movement(From end of surgery to 8h or time to first intake of rescue medication (whichever came first))
- Pain at Rescue Medication(At time of first rescue medication taken before 8 hours after end of surgery)
- Pain at Jaw Movement at Time of First Rescue Medication(At time of first rescue medication (before 8 hours after end on surgery))
- Time to First Intake of Rescue Medication.(From end of surgery to 8 hours following surgery)
- Number of Patients Requesting Rescue Medication(End of surgery up to 8hours following surgery)
- Maximum Deterioration in Visual Analogue Mood Scale (VAMS) Stimulated(Between dosing and 12h post-dose)
- Maximum Deterioration in VAMS High(Between dosing and 12h post-dose)
- Maximum Deterioration in VAMS Anxious(Between dosing and 12h post-dose)
- Maximum Deterioration in VAMS Sedated(Between dosing and 12h post-dose)
- Maximum Deterioration in VAMS Down(Between dosing and 12h post-dose)
- Time to Max Deterioration in VAMS Stimulated(Between dosing and 12h post-dose)
- Time to Max Deterioration in VAMS High(Between dosing and 12h post-dose)
- Time to Max Deterioration in VAMS Anxious(Between dosing and 12h post-dose)
- Time to Max Deterioration in VAMS Sedated(Between dosing and 12h post-dose)
- Time to Max Deterioration in VAMS Down(Between dosing and 12h post-dose)