A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Naproxen [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 254
- 试验地点
- 1
- 主要终点
- Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0
研究概览
简要总结
The purpose of the study is to determine whether Naproxen Test Formulation Capsules are safe and effective for 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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient is male or female between 18 and 50 years of age
- •For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
- •Patient requires extraction of 2 or more third molars
- •Patient must be willing to stay at the study site overnight
排除标准
- •Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
- •Patient has a current disease or history of a disease that will impact the study or the patient's well-being
- •Patient has used or intends to use any of the medications that are prohibited by the protocol
- •Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
- •Patient has taken another investigational drug within 30 days prior to screening
研究组 & 干预措施
Naproxen Test (lower dose)
200-mg
干预措施: Naproxen Test (Drug)
Naproxen Test (upper dose)
400-mg (2 x 200-mg)
干预措施: Naproxen Test (Drug)
Naprosyn 250 mg
干预措施: Naprosyn (Drug)
Naprosyn 500 mg
干预措施: Naprosyn (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Analysis of Total Pain Relief (TOTPAR) Over 0 to 12 Hours (TOTPAR-12) After Time 0
时间窗: Over 0 to 12 Hours
Total pain relief as computed as a time-weighted sum of individual patient pain relief scores at each timepoint from 0-12 hours. Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60.
次要结局
未报告次要终点