A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY COMPARING THE ANALGESIC EFFICACY AND SAFETY OF A SINGLE ORAL DOSE OF A NOVEL FIXED-DOSE COMBINATION OF IBUPROFEN 400 MG WITH CAFFEINE 100 MG TO IBUPROFEN 400 MG AND TO PLACEBO IN THE TREATMENT OF POST-SURGICAL DENTAL PAIN IN OTHERWISE HEALTHY SUBJECTS
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 374
- 试验地点
- 1
- 主要终点
- Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen
研究概览
简要总结
An efficacy study assessing analgesic effect of ibuprofen/caffeine in post-surgical dental pain.
详细描述
The purpose of this study is to assess the analgesic efficacy of a fixed dose combination of ibuprofen/caffeine compared to ibuprofen alone and also to 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
- Triple (Participant, 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
- •Males and females 16 years to 40 years of age (inclusive).
- •Subjects who have undergone outpatient surgical extraction of 3 or more third molars, of which at least 2 must be a partial or complete bony mandibular impaction within 30 days of Screening and have met baseline pain criteria as described in this protocol
- •Examined by the attending dentist or physician and medically cleared to participate in the study.
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, metabolic or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) determined by the Investigator to place the subject at increased risk including the presence or history within 2 years of screening of the following medical conditions/disorders:
- •Bleeding disorder;
- •Gastrointestinal ulcer or gastrointestinal bleeding;
- •Paralytic ileus or other gastrointestinal obstructive disorders.
- •Pregnant female subjects; breastfeeding female subjects; fertile male subjects and female subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception
- •Hypersensitivity to ibuprofen, naproxen, aspirin, or any other NSAID, caffeine, or other component of the product.
研究组 & 干预措施
Ibuprofen/Caffeine
Ibuprofen 400 mg/ Caffeine 100 mg fixed-dose combination
干预措施: Ibuprofen/Caffeine (Drug)
Ibuprofen
Ibuprofen 400 mg
干预措施: Ibuprofen (Drug)
Placebo
Placebo comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Time Weighted Sum of Pain Relief Rating (PRR) and Pain Intensity Difference (PID) Scores From 0 to 8 Hours Post-dose (SPRID 0-8): Ibuprofen + Caffeine Versus Ibuprofen
时间窗: From 0 to 8 hours post-dose on Day 1
SPRID 0-8: time-weighted sum of PRID scores from 0 to 8 hours. PRID: sum of PID and PRR at each post-dose time point. PRR score: at each post-dose time point participants answered to question "How much relief do you have from your starting pain?" on a 5-point scale: 0= none, 1= a little, 2= some, 3= a lot, 4= complete; higher scores = more relief from pain. Numerical pain severity rating (NPSR) scale: at baseline and each post-dose time point participants answered to question "How much pain do you have at this time?" on an 11-point scale: range from 0= no pain to 10= worst possible pain; higher scores = worse pain. PID score: NPSR score at baseline (0 hour) minus NPSR score at each post-dose time point; overall possible PID score range at a post-dose time point: -10 to 10, higher positive value = greater improvement. Overall possible SPRID 0-8 score range: -80 to 112, higher scores = more improvement in pain.
次要结局
- Time to Treatment Failure(Up to 8 hours post dose on Day 1)
- Pain Relief Rating Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose(0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1)
- Time Weighted Sum of Pain Relief Rating and Pain Intensity Difference Scores From 0 to 2 (SPRID 0-2), 0 to 4 (SPRID 0-4), 0 to 6 (SPRID 0-6) and 0 to 8 Hours Post-dose (SPRID 0-8)(From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1)
- Time Weighted Sum of Pain Intensity Difference Scores From 0 to 2 Hours (SPID 0-2), 0 to 4 (SPID 0-4), 0 to 6 (SPID 0-6) and 0 to 8 Hours Post-dose (SPID 0-8)(From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1)
- Time Weighted Sum of Pain Relief Rating Scores From 0 to 2 (TOTPAR 0-2), 0 to 4 (TOTPAR 0-4), 0 to 6 (TOTPAR 0-6) and 0 to 8 Hours Post-dose (TOTPAR 0-8)(From 0 to 2, 0 to 4, 0 to 6 and 0 to 8 hours post-dose on Day 1)
- Sum of Pain Relief Rating and Pain Intensity Difference (PRID) Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours post-dose on Day 1)
- Pain Intensity Difference Scores at 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 Hours Post-dose(0.25, 0.5, 1, 1.5, 2, 3, 4 5, 6, 7, and 8 hours post-dose on Day 1)
- Time to Onset of Achieving Meaningful Relief(Up to 8 hours post-dose on Day 1)
- Time to Onset of First Perceptible Relief(Up to 8 hours post-dose on Day 1)