A Randomized, Double-Blind, Placebo-Controlled Trial to Compare the Duration of Analgesic Efficacy and Safety of Naproxen Sodium Tablets and Ibuprofen Tablets in Postsurgical Dental Pain
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 387
- 试验地点
- 1
- 主要终点
- Time to First Use of Rescue Medication
研究概览
简要总结
To compare the duration of analgesic efficacy as determined by the time to rescue medication of a single oral dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo over 24 hours in subjects experiencing moderate to severe post-impaction surgery dental pain.
To compare the overall analgesic effect (SPID 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
To compare the overall relief from pain (TOTPAR 0-24) of a single dose of naproxen sodium 440 mg (2 x 220 mg tablets) relative to ibuprofen 400 mg (2 x 200 mg tablets) and placebo.
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
- 16 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy, ambulatory, male or female volunteers 16-40 years of age;
- •Body mass index 18.0 to 30.0 kg/m^2 inclusive;
- •Scheduled to undergo surgical removal of at least 2 mandibular partial or full bony impacted third molars. Up to two maxillary third molars may be removed regardless of impaction level. Supernumerary teeth present may also be removed at the discretion of the oral surgeon;
- •Mandibular molars must demonstrate modified Demirjian root classification stage D, E, F, G or H;
排除标准
- •History of hypersensitivity to naproxen sodium, ibuprofen, nonsteroidal anti-inflammatory drugs (NSAIDS), aspirin, similar pharmacological agents, local anesthetics, rescue medication or components of the investigational products;
- •Evidence or history of clinically significant (in the judgment of the investigator) hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies within the last 5 years;
- •Relevant concomitant disease such as asthma (exercise induced asthma is permitted)
研究组 & 干预措施
Naproxen Sodium (Aleve, BAY117031)
Participants received one single dose of 440 mg naproxen sodium tablets (200 mg x 2 tablets, oral) after randomization
干预措施: Naproxen Sodium (Aleve, BAY117031) (Drug)
Ibuprofen (Advil)
Participants received one single dose of 400 mg ibuprofen tablets (200 mg x 2 tablets, oral) after randomization
干预措施: Ibuprofen (Advil) (Drug)
Placebo
Participants received one single dose of matching placebo tablets (2 tablets, oral) after randomization
干预措施: Placebo (Drug)
结局指标
主要结局
Time to First Use of Rescue Medication
时间窗: Up to 24 hours
Time to first use of rescue medication was estimated using Kaplan-Meier method. If a subject did not take the rescue medication during the treatment period, (s)he was censored at the time of last assessment.
次要结局
- Sum of Pain Intensity Difference (SPID)(Up to 24 hours)
- Total Pain Relief (TOTPAR)(Up to 24 hours)