A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group Analgesic Efficacy Trial of Oral ARRY-371797 in Subjects Undergoing Third Molar Extraction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR).
研究概览
简要总结
This is a Phase 2 study designed to test the ability of investigational study drug ARRY-371797 to reduce pain in a postoperative pain model (third molar extraction), and to further evaluate the drug's safety. Approximately 250 subjects from the US will be enrolled in this study.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled for outpatient oral surgical procedure to remove 3 or more third molars, at least 1 of which is mandibular and fully or partially impacted by bone.
- •Females of childbearing potential must be willing to use an acceptable method of contraception within 14 days prior to first dose of study drug until the completion of the follow-up procedures.
- •Body weight >50 kg (110 lbs).
- •Good health determined by medical history, physical examination, vital signs and clinical laboratory results of non-clinical significance.
- •Additional criteria exist.
排除标准
- •Evidence or history of clinically significant dermatologic, hematological, renal, endocrine (e.g. poorly controlled diabetes), pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, or allergic disease (including clinically significant drug allergies that could impact the conduct of this study, but excluding untreated, asymptomatic, seasonal allergies at time of study drug dosing).
- •Positive urine drug screen within 28 days prior to first dose of study drug.
- •Use of prohibited prescription drugs, or grapefruit juice within 7 days of first dose of study drug; prohibited medications are defined as nonsteroidal and steroidal antiinflammatory drugs, analgesics including opioids (except low dose aspirin for myocardial infarction prophylaxis), P450 CYP3A substrates or inhibitors (strong or moderate).
- •Additional criteria exist.
研究组 & 干预措施
Placebo, ARRY-371797
干预措施: Placebo; oral (Drug)
Placebo
干预措施: Placebo; oral (Drug)
Placebo, ARRY-371797
干预措施: ARRY-371797, p38 inhibitor; oral (Drug)
ARRY-371797, Placebo
干预措施: ARRY-371797, p38 inhibitor; oral (Drug)
ARRY-371797, Placebo
干预措施: Placebo; oral (Drug)
ARRY-371797
干预措施: ARRY-371797, p38 inhibitor; oral (Drug)
Celecoxib, Placebo
干预措施: Celecoxib, COX-2 inhibitor; oral (Drug)
Celecoxib, Placebo
干预措施: Placebo; oral (Drug)
Celecoxib, ARRY-371797
干预措施: Celecoxib, COX-2 inhibitor; oral (Drug)
Celecoxib, ARRY-371797
干预措施: ARRY-371797, p38 inhibitor; oral (Drug)
结局指标
主要结局
Assess the efficacy of the study drug dosed postoperatively in terms of total pain relief (TOTPAR).
时间窗: 6 hours post-dose
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs.
时间窗: Duration of study
次要结局
- Assess the efficacy of the study drug (versus placebo and celecoxib) in terms of pain relief measurements [including TOTPAR, total pain intensity (TPI) and time to rescue medication].(Duration of study)