Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain: Study I
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 335
- 主要终点
- Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)
研究概览
简要总结
This study will compare the pain relieving effect of a single-dose of a novel ibuprofen formulation to placebo and two formulations of standard ibuprofen in the treatment of post-surgical dental pain following "wisdom" tooth (third molar) removal.
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
- •Normal, healthy males and females 16 to 40 years of age
- •Outpatients who have moderate to severe post-operative pain (confirmed by a Visual Analog Scale-Pain Severity Rating [VAS-PSR] score of at least 50 mm on a 100 mm VAS-PSR) following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction
- •Use of only the following pre-operative medication(s)/anesthetic(s): topical benzocaine, a short acting parenteral (local) anesthetic (mepivacaine or lidocaine) with or without vasoconstrictor and/or nitrous oxide
排除标准
- •Pregnancy or breast-feeding
- •Alcohol or substance abuse
- •Any serious medical or psychiatric disorder
- •History of stomach ulcers, stomach bleed, or other bleeding disorders
- •Use of a prescription or over-the-counter drug with which administration of ibuprofen or any other non-steroidal anti-inflammatory drug, acetaminophen, or hydrocodone is contraindicated (including: opioids, antipsychotics, antianxiety agents, or other central nervous system depressants[including alcohol])
研究组 & 干预措施
Treatment A
干预措施: Novel Ibuprofen (Drug)
Treatment B
干预措施: Standard Ibuprofen (Drug)
Treatment C
干预措施: Standard Ibuprofen (Drug)
Treatment D
干预措施: Placebo (Drug)
结局指标
主要结局
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)
时间窗: 0 to 8 hours
SPRID: time-weighted sum of pain relief rating combined with pain intensity difference (PRID) over 8 hours. SPRID 0-8 score range: -8 (worst) to 56 (best). PRID: sum of Pain intensity differences (PID) and pain relief rating (PRR) at each time point. PRID score range: -1=worst to 7=best. PID: baseline pain severity score minus pain severity score at a given time point (pain severity score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe). PID score range: -1(worst) to 3 (best). PRR: assessed on 5-point pain relief rating scale (0=No relief to 4=Complete relief).
Time to Onset of Meaningful Relief
时间窗: 0 to 8 hours
Participants evaluated the time to meaningful relief by stopping a second stopwatch labeled 'meaningful relief' at the moment they first began to experience meaningful relief. Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.
次要结局
- Time to Confirmed First Perceptible Relief(0 to 8 hours)
- Pain Relief Rating (PRR)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours)
- Pain Intensity Difference (PID)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours)
- Sum of Pain Relief Rating and Pain Intensity Difference (PRID)(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours)
- Time-weighted Sum of Pain Intensity Difference (SPID)(0-2, 0-3, 0-6, 0-8 hours)
- Time-weighted Sum of Pain Relief Rating (TOTPAR)(0-2, 0-3, 0-6, 0-8 hours)
- Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)(0-2, 0-3, 0-6, 0-8 hours)
- Cumulative Percentage of Participants With Meaningful Relief(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours)
- Cumulative Percentage of Participants With Confirmed First Perceptible Relief(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours)
- Cumulative Percentage of Participants With Treatment Failure(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours)
- Cumulative Percentage of Participants With Complete Relief(0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours)
- Participant Global Evaluation of Study Medication(8 hours)
- Time to Treatment Failure(0 to 8 hours)