NCT01529346已完成2 期
A Randomized, Double-blind, Double-dummy, Parallel Group, Placebo Controlled Study Assessing The Efficacy Of Single Doses Of Pf-05089771 For The Treatment Of Postoperative Dental Pain Using Ibuprofen 400 Mg As Positive Control
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 235
- 试验地点
- 3
- 主要终点
- Total Pain Relief From 0 to 6 Hours (TOTPAR[6])
研究概览
简要总结
The objective of this study is to evaluate the overall pain relief of a single dose of PF-05089771 against placebo following third molar extraction.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Oral surgery having removed 2 unilateral third molar teeth.
- •Pre-dose pain intensity score (100 mm VAS [VAS]) of at least 50mm within 5 hours of oral surgery
- •Pre-dose pain intensity score of moderate or severe within 5 hours of oral surgery
排除标准
- •Presence or known history of any clinically significant hematological, hepatic, renal, endocrine, cardiovascular, neurological, psychiatric, gastrointestinal, pulmonary, allergic (including known drug hypersensitivities or allergies, but excluding untreated asymptomatic seasonal allergy) or any metabolic disorder that may increase risk associated with study participation, investigational drug administration or may interfere with interpretation of study results.
- •Prior use of any type of analgesic or NSAID within 5-half lives of that drug or less before taking the first dose of study medication, except for anesthesia for the procedure.
- •Active dental infection at the time of surgery.
- •Recent (within the previous 12 months) history of chronic analgesic or tranquiliser dependency.
- •Any significant oral surgery complication at the time of surgery or in the immediate postoperative period, or oral surgery that has lasted more than 30 minutes (time from first incision to last suture placement).
- •Subjects who smoke more than 1 pack (20 cigarettes) per day, more than 3 cigars per day or use smokeless tobacco on a daily basis are excluded from the study.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Other)
PF-05089771 1600 mg
Experimental
干预措施: PF-05089771 (Drug)
PF-05089771 1600 mg
Experimental
干预措施: Placebo (Other)
PF-05089771 450 mg
Experimental
干预措施: PF-05089771 (Drug)
PF-05089771 450 mg
Experimental
干预措施: Placebo (Other)
PF-05089771 150 mg
Experimental
干预措施: PF-05089771 (Drug)
PF-05089771 150 mg
Experimental
干预措施: Placebo (Other)
Ibuprofen 400 mg
Active Comparator
干预措施: Ibuprofen (Drug)
Ibuprofen 400 mg
Active Comparator
干预措施: Placebo (Other)
结局指标
主要结局
Total Pain Relief From 0 to 6 Hours (TOTPAR[6])
时间窗: 0 to 6 hours
TOTPAR(6) was defined as the total area under pain relief (PR) curve through first 6 hours after dosing, calculated using trapezoidal rule. PR was assumed to be 0 at 0 hour. PR assessed on a 5-point categorical scale: 0(none), 1 (a little), 2 (some), 3 (a lot) and 4 (complete), at different time points during study up to 6 hours. Total score range for TOTPAR(6): 0 (worst) to 24 (best), higher value indicated greater degree of PR. Posterior mean, standard deviation were estimated based on analysis of covariance (ANCOVA) model with non-informative priors within outlier robust Bayesian framework.
次要结局
- Number of Participants With Peak Pain Relief (PPR)(0 to 24 hours)
- Pain Relief (PR) Score(15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours)
- Pain Intensity Difference (PID)(15, 30, 45, 60, 90 minutes, 2, 3, 4, 6, 8, 24 hours)
- Summed Pain Intensity Difference (SPID)(0 to 6 hours; 0 to 24 hours)
- Total Pain Relief From 0 to 24 Hours (TOTPAR[24])(0 to 24 hours)
- Time to Onset of First Perceptible Pain Relief(0 to 24 hours)
- Time to Onset of Meaningful Pain Relief(0 to 24 hours)
- Number of Participants With Global Evaluation of Study Medication(6, 24 hours, prior to rescue medication (assessed up to 24 hours))
- Number of Participants With Study Medication Satisfaction(6, 24 hours, prior to rescue medication (assessed up to 24 hours))
- Plasma PF-05089771 Concentration(0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose)
- Plasma Ibuprofen Concentration(0 (pre-dose), 0.5, 1, 2, 4, 6, 8, 10, 24 hours post-dose)
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities(Baseline up to Day 7 to 10 (follow-up))
- Time to First Use of Rescue Medication(0 to 24 hours)
- Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)(Baseline up to Day 28 (follow-up))
- Number of Participants With Clinically Significant Laboratory Findings(Baseline up to Day 7 to 10 (follow-up))
- Number of Participants With Clinically Significant Vital Signs(Baseline up to Day 7 to 10 (follow-up))
研究者
研究点 (3)
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