A RANDOMIZED, DOUBLE-BLIND, PLACEBO-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
- 103
- 试验地点
- 1
- 主要终点
- Assess the efficacy of the study drug dosed either perioperatively or postoperatively in terms of total pain relief (TOTPAR) and total pain intensity (visual analog scale, VAS).
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 either perioperatively or postoperatively in a third molar extraction pain model, and to further evaluate the drug's safety. Approximately 150 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
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（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 2 ipsilateral 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
- •Positive urine drug screen.
- •Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins, or grapefruit juice within 14 days prior to first dose of study drug.
- •Additional criteria exist.
研究组 & 干预措施
Placebo, ARRY-371797
干预措施: ARRY-371797, p38 inhibitor; oral (Drug)
ARRY-371797
干预措施: ARRY-371797, p38 inhibitor; oral (Drug)
Placebo, ARRY-371797
干预措施: Placebo; oral (Drug)
Placebo
干预措施: Placebo; oral (Drug)
结局指标
主要结局
Assess the efficacy of the study drug dosed either perioperatively or postoperatively in terms of total pain relief (TOTPAR) and total pain intensity (visual analog scale, VAS).
时间窗: 6 hours post dose 2
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
- Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS).(Duration of study)