A Double-Blind, Double-Dummy, Placebo- and Active Controlled Evaluation of the Efficacy, Safety and Tolerability of Buprenorphine HCl Buccal Film in the Treatment of Pain Associated With Third Molar Extraction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Sum of Pain Intensity Difference From Baseline to 8 Hours
研究概览
简要总结
The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental 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
- Double (Participant, 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
- 否
入选标准
- •extraction of 2 or more third molars, at least 1 of which must be fully or partially impacted in mandibular bone
- •males or non-pregnant females, aged 18 to 45 years
- •good general health and capable of providing informed consent
排除标准
- •history of substance abuse or dependence
- •positive urine toxicology screen or alcohol breath test
- •history of hypersensitivity to or allergy to any study drug
- •donation of blood within prior 30 days
- •use of analgesics, caffeine, sedatives, antidepressants, anticoagulant or antiplatelet agents within 24 hours
研究组 & 干预措施
Standard Opioid
Oxycodone 5-mg oral capsule and 2 buccal placebo films
干预措施: Oxycodone (Drug)
Standard Opioid
Oxycodone 5-mg oral capsule and 2 buccal placebo films
干预措施: Placebo Film (Drug)
High Dose buprenorphine HCl buccal film
Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule
干预措施: Buprenorphine (Drug)
High Dose buprenorphine HCl buccal film
Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule
干预措施: Placebo Film (Drug)
Mid Dose buprenorphine HCl buccal film
Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule
干预措施: Buprenorphine (Drug)
High Dose buprenorphine HCl buccal film
Buprenorphine HCl buccal film 0.5-mg modified formulation 1, buccal placebo film, and oral placebo capsule
干预措施: Placebo Capsule (Drug)
Mid Dose buprenorphine HCl buccal film
Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule
干预措施: Placebo Film (Drug)
Mid Dose buprenorphine HCl buccal film
Buprenorphine HCl buccal film 0.5-mg modified formulation 2, buccal placebo film, and oral placebo capsule
干预措施: Placebo Capsule (Drug)
Low Dose buprenorphine HCl buccal film
Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule
干预措施: Buprenorphine (Drug)
Low Dose buprenorphine HCl buccal film
Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule
干预措施: Placebo Film (Drug)
Low Dose buprenorphine HCl buccal film
Buprenorphine HCl buccal film 0.25-mg modified formulation 2, buccal placebo film, and oral placebo capsule
干预措施: Placebo Capsule (Drug)
Placebo
Oral placebo capsule and 2 buccal placebo films
干预措施: Placebo Film (Drug)
Placebo
Oral placebo capsule and 2 buccal placebo films
干预措施: Placebo Capsule (Drug)
结局指标
主要结局
Sum of Pain Intensity Difference From Baseline to 8 Hours
时间窗: Baseline, 8 hours
Time-weighted sum of pain intensity difference from baseline to 8 hours (SPID-8) where total score ranges from -80 (worst) to 80 (best) and a higher value indicates greater pain relief. Pain intensity was recorded using an 11-point numeric rating scale (NRS), where 0=none and 10=worst pain imaginable, in response to "What is your pain level at this time?"
次要结局
- Sum of Pain Relief and Intensity Differences Over 8 Hours(8 hours)
- Sum of Pain Relief and Intensity Differences Over 2 Hours(2 hours)
- Peak Pain Intensity Difference(24 hours)
- Peak Pain Relief(24 hours)
- Onset of Analgesia(8 hours)
- Duration of Analgesia(24 hours)
- Percentage of Participants Reporting a Global Rating of Study Drug as "Excellent"(8 hours and 24 hours)
- Total Pain Relief Over 8 Hours(8 hours)
- Percentage of Participants With "Excellent" Investigator Global Rating of Study Drug(24 hours)
- Change From Baseline in Cognitive Assessment Using CNS-VS(Baseline (screening), 2 hours 15 minutes postdose)