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临床试验/NCT01115673
NCT01115673已完成3 期

A Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Safety and Efficacy Study of Acetaminophen 1000 mg and Acetaminophen 650 mg in Post Operative Dental Pain

McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.1 个研究点 分布在 1 个国家目标入组 540 人开始时间: 2010年6月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
540
试验地点
1
主要终点
Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.

详细描述

This trial is to assess the relative efficacy of acetaminophen 1000 mg versus acetaminophen 650 mg over a six-hour period, in subjects experiencing at least moderate post-operative 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
Double (Participant, Investigator)

入排标准

年龄范围
16 Years 至 50 Years（Child, Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Must be at least 16 and less than 51 years of age
  • •Must weigh at least 100 lbs with a body mass index of at least 18 and less than 30
  • •Must have up to four of their back teeth (third-molars) pulled

排除标准

  • •Cannot be allergic to acetaminophen (Tylenol)
  • •Cannot be pregnant (or planning to be pregnant) or nursing a baby
  • •Cannot have any other medical conditions that the investigator determines might compromise your safety or the study results

研究组 & 干预措施

ACE-1000

Experimental

1000 mg Acetaminophen Caplet

干预措施: Acetaminophen (Drug)

ACE-650

Active Comparator

650 mg Acetaminophen Caplet

干预措施: Acetaminophen (Drug)

ACE-0

Placebo Comparator

0 mg Acetaminophen Caplet

干预措施: Placebo Control (Drug)

结局指标

主要结局

Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)

时间窗: 6 Hours

Weighted Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6) - pain intensity and pain relief were evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain for pain intensity and 0 = no relief and 100 = complete relief for pain relief. For SPRID6, the total possible minimum value is -300 (worst) and the total possible maximum value is 1200 (best). The weights used in the calculation of weighted sums were equal to the elapsed time (hour) between the time point of interest and the preceding time point.

次要结局

  • Sum of Pain Intensity Difference Over Six Hours (SPID6)(6 Hours)
  • Sum of Pain Relief Scores Over Six Hours (TOTPAR6)(6 Hours)
  • Pain Relief (PAR) Scores at 75 Minutes(75 Minutes)
  • Pain Intensity Difference (PID) at 15 Minutes(15 Minutes)
  • Pain Intensity Difference (PID) at 30 Minutes(30 Minutes)
  • Pain Intensity Difference (PID) at 45 Minutes(45 Minutes)
  • Pain Intensity Difference (PID) at 60 Minutes(60 Minutes)
  • Pain Intensity Difference (PID) at 75 Minutes(75 Minutes)
  • Pain Intensity Difference (PID) at 90 Minutes(90 Minutes)
  • Pain Intensity Difference (PID) at 120 Minutes(120 Minutes)
  • Pain Intensity Difference (PID) at 180 Minutes(180 Minutes)
  • Pain Intensity Difference (PID) at 240 Minutes(240 Minutes)
  • Pain Intensity Difference (PID) at 300 Minutes(300 Minutes)
  • Pain Intensity Difference (PID) at 360 Minutes(360 Minutes)
  • Pain Relief (PAR) Scores at 15 Minutes(15 Minutes)
  • Pain Relief (PAR) Scores at 30 Minutes(30 Minutes)
  • Pain Relief (PAR) Scores at 45 Minutes(45 Minutes)
  • Pain Relief (PAR) Scores at 60 Minutes(60 Minutes)
  • Pain Relief (PAR) Scores at 90 Minutes(90 Minutes)
  • Pain Relief (PAR) Scores at 120 Minutes(120 Minutes)
  • Pain Relief (PAR) Scores at 180 Minutes(180 Minutes)
  • Pain Relief (PAR) Scores at 240 Minutes(240 Minutes)
  • Pain Relief (PAR) Scores at 300 Minutes(300 Minutes)
  • Pain Relief (PAR) Scores at 360 Minutes(360 Minutes)
  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes(15 Minutes)
  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes(30 Minutes)
  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes(45 Minutes)
  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes(60 Minutes)
  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes(75 Minutes)
  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes(90 Minutes)
  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes(120 Minutes)
  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes(180 Minutes)
  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes(240 Minutes)
  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes(300 Minutes)
  • Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes(360 Minutes)
  • Time to Meaningful Pain Relief(within 6 Hours)
  • Time to Confirmed Perceptible Pain Relief(within 6 Hours)
  • Duration of Analgesia - Time to Rescue(within 6 Hours)
  • Rescue Rates Through Four Hours(through 4 Hours)
  • Rescue Rates Through Six Hours(through 6 Hours)
  • Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score(6 Hours)
  • Patient Global Evaluation(6 Hours)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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