To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
2012年4月26日 更新者：McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
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
The objective of this study is to evaluate the safety and efficacy of acetaminophen 650 mg and acetaminophen 1000 mg in dental surgery.
研究概览
详细说明
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.
研究类型
介入性
注册 (实际的)
540
阶段
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Utah
-
Salt Lake City、Utah、美国、84124
- Jean Brown Research
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
16年 至 50年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：ACE-1000
1000 mg Acetaminophen Caplet
|
Acetaminophen Caplet - single dose
其他名称：
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有源比较器：ACE-650
650 mg Acetaminophen Caplet
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Acetaminophen Caplet - single dose
其他名称：
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安慰剂比较：ACE-0
0 mg Acetaminophen Caplet
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0 mg Caplet - single dose
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
大体时间：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.
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6 Hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Sum of Pain Intensity Difference Over Six Hours (SPID6)
大体时间：6 Hours
|
Weighted Sum of the Pain Intensity Difference from Baseline Over Six Hours (SPID6) - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain.
The total possible minimum value is -300 (worst) and the total possible maximum value is 600 (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.
|
6 Hours
|
|
Sum of Pain Relief Scores Over Six Hours (TOTPAR6)
大体时间：6 Hours
|
Weighted Sum of the Pain Relief Scores Over Six Hours (TOTPAR6) - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief.
The total possible minimum value is 0 (worst) and the total possible maximum value is 600 (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.
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6 Hours
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Pain Intensity Difference (PID) at 15 Minutes
大体时间：15 Minutes
|
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
|
15 Minutes
|
|
Pain Intensity Difference (PID) at 30 Minutes
大体时间：30 Minutes
|
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
|
30 Minutes
|
|
Pain Intensity Difference (PID) at 45 Minutes
大体时间：45 Minutes
|
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
|
45 Minutes
|
|
Pain Intensity Difference (PID) at 60 Minutes
大体时间：60 Minutes
|
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
|
60 Minutes
|
|
Pain Intensity Difference (PID) at 75 Minutes
大体时间：75 Minutes
|
Pain Intensity Difference (PID) from Baseline at Each Assessment Time Point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
|
75 Minutes
|
|
Pain Intensity Difference (PID) at 90 Minutes
大体时间：90 Minutes
|
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
|
90 Minutes
|
|
Pain Intensity Difference (PID) at 120 Minutes
大体时间：120 Minutes
|
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
|
120 Minutes
|
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Pain Intensity Difference (PID) at 180 Minutes
大体时间：180 Minutes
|
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
|
180 Minutes
|
|
Pain Intensity Difference (PID) at 240 Minutes
大体时间：240 Minutes
|
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
|
240 Minutes
|
|
Pain Intensity Difference (PID) at 300 Minutes
大体时间：300 Minutes
|
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
|
300 Minutes
|
|
Pain Intensity Difference (PID) at 360 Minutes
大体时间：360 Minutes
|
Pain Intensity Difference (PID) from Baseline at Each Assessment Time point - pain intensity was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no pain and 100 = very severe pain with a highest possible score of 100.
The pain intensity difference was calculated at each time point as the pain intensity score at baseline minus the pain intensity score at the stated time point.
|
360 Minutes
|
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Pain Relief (PAR) Scores at 15 Minutes
大体时间：15 Minutes
|
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
|
15 Minutes
|
|
Pain Relief (PAR) Scores at 30 Minutes
大体时间：30 Minutes
|
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
|
30 Minutes
|
|
Pain Relief (PAR) Scores at 45 Minutes
大体时间：45 Minutes
|
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
|
45 Minutes
|
|
Pain Relief (PAR) Scores at 60 Minutes
大体时间：60 Minutes
|
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
|
60 Minutes
|
|
Pain Relief (PAR) Scores at 75 Minutes
大体时间：75 Minutes
|
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
|
75 Minutes
|
|
Pain Relief (PAR) Scores at 90 Minutes
大体时间：90 Minutes
|
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
|
90 Minutes
|
|
Pain Relief (PAR) Scores at 120 Minutes
大体时间：120 Minutes
|
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
|
120 Minutes
|
|
Pain Relief (PAR) Scores at 180 Minutes
大体时间：180 Minutes
|
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
|
180 Minutes
|
|
Pain Relief (PAR) Scores at 240 Minutes
大体时间：240 Minutes
|
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
|
240 Minutes
|
|
Pain Relief (PAR) Scores at 300 Minutes
大体时间：300 Minutes
|
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
|
300 Minutes
|
|
Pain Relief (PAR) Scores at 360 Minutes
大体时间：360 Minutes
|
Pain Relief Scores at each Assessment Timepoint - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 100
|
360 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 15 Minutes
大体时间：15 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
|
15 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 30 Minutes
大体时间：30 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
|
30 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 45 Minutes
大体时间：45 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
|
45 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 60 Minutes
大体时间：60 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
|
60 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 75 Minutes
大体时间：75 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
|
75 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 90 Minutes
大体时间：90 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
|
90 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 120 Minutes
大体时间：120 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
|
120 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 180 Minutes
大体时间：180 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
|
180 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 240 Minutes
大体时间：240 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
|
240 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 300 Minutes
大体时间：300 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
|
300 Minutes
|
|
Sum of Pain Intensity Difference and Pain Relief Scores (PRID) at 360 Minutes
大体时间：360 Minutes
|
Sum of PID and PAR Scores (PRID) at each Assessment Time point - 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
|
360 Minutes
|
|
Time to Meaningful Pain Relief
大体时间：within 6 Hours
|
Minutes until meaningful pain relief was achieved.
A stopwatch was provided to the subject after ingestion of the study medication.
The subject was instructed to stop the stopwatch when the relief from the starting pain was meaningful to them.
|
within 6 Hours
|
|
Time to Confirmed Perceptible Pain Relief
大体时间：within 6 Hours
|
Minutes until confirmed perceptible pain relief was achieved.
A stopwatch was provided to the subject after ingestion of the study medication.
The subject was instructed to stop the stopwatch when they first began to feel any pain relieving effect whatsoever of the drug, that was when they first felt any pain relief.
It did not necessarily mean they felt completely better, although they might have, but when they first felt any difference in the pain.
|
within 6 Hours
|
|
Duration of Analgesia - Time to Rescue
大体时间：within 6 Hours
|
Minutes until rescue medication was given.
|
within 6 Hours
|
|
Rescue Rates Through Four Hours
大体时间：through 4 Hours
|
Percentage of subjects using rescue medication.
|
through 4 Hours
|
|
Rescue Rates Through Six Hours
大体时间：through 6 Hours
|
Percentage of subjects using rescue medication.
|
through 6 Hours
|
|
Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score
大体时间：6 Hours
|
Percentage of Subjects with >50% of the Maximum Possible TOTPAR6 Score - pain relief was evaluated using a 0-100 mm visual analog scale (VAS) where 0 = no relief and 100 = complete relief with a highest possible score of 600 so >50% is >300 out of 600
|
6 Hours
|
|
Patient Global Evaluation
大体时间：6 Hours
|
Patient Assessment of the Pain Medication - Number of Subjects rating the medication they received as a pain reliever on a score of 0-4, where 0=poor, 1=fair, 2=good, 3=very good, 4=excellent
|
6 Hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Daniel Qi, M.D.、McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年6月1日
初级完成 (实际的)
2011年1月1日
研究完成 (实际的)
2011年1月1日
研究注册日期
首次提交
2010年4月30日
首先提交符合 QC 标准的
2010年5月3日
首次发布 (估计)
2010年5月4日
研究记录更新
最后更新发布 (估计)
2012年5月28日
上次提交的符合 QC 标准的更新
2012年4月26日
最后验证
2012年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.