A Double-blind, Randomized, Placebo and Naproxen Controlled Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386, 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
- 103
- 试验地点
- 1
- 主要终点
- Sum of Pain Intensity Difference in Percent (SPID%)
研究概览
简要总结
The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of AZD1386 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.
排除标准
- •History of somatic disease/condition, which may interfere with the objectives for the study, as judged by the investigator.
- •Clinically significant illness or clinically relevant trauma within the 2 weeks prior to the administration of the investigational product, as judged by the investigator.
- •A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst first degree relatives
- •Patients with a body temperature >37.5°C at Visit 2, before start of surgical procedures
研究组 & 干预措施
Placebo
Placebo matching AZD1386
干预措施: Placebo (Drug)
AZD1386
干预措施: AZD1386 (Drug)
Naproxen
干预措施: Naproxen (Drug)
结局指标
主要结局
Sum of Pain Intensity Difference in Percent (SPID%)
时间窗: from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours
Weighted sum of the pain intensity (PI) differences in percent for the given time frame. PI values are weighted according to the time since the previous PI assessment (or the time of administration of the investigational product for the first post-dose assessment). SPID% = elapsed since previous value, where is the PI difference in percent at assessment t. High values=good effect, low values=poor effect Pointwise assessments of pain are measured using a VAS scale (0-100 mm), as described in the secondary outcome measure (PI).
次要结局
- Time to First Meaningful Pain Relief(from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours)
- Pain Intensity (PI) by Using Visual Analogue Scale (VAS) (0-100 mm)(Immediately prior to administration of investigational product (IP). After intake of IP assessment will be made every 15 min for the first 2 h, at 2h and 30 min, 3 h and thereafter every hour up to 8 h after intake of IP.)
- Time to First Perceptible Pain Relief(from the start of administration of the investigational product up to the time of first administration of rescue analgesic or up to a maximum of 8 hours)
- VAS Pain Intensity at Rescue Intake(at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product)
- VAS Pain on Jaw Movement at Rescue Intake(at the time of first administration of rescue analgesic, up to the maximum time of 8 hours after intake of the investigational product)