- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01115673
To Evaluate the Safety and Efficacy of Acetaminophen 650 mg and 1000mg in Dental Pain After Surgery
2012년 4월 26일 업데이트: 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.
연구 개요
상세 설명
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.
연구 유형
중재적
등록 (실제)
540
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
Utah
-
Salt Lake City, Utah, 미국, 84124
- Jean Brown Research
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
16년 (어린이, 성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: ACE-1000
1000 mg Acetaminophen Caplet
|
Acetaminophen Caplet - single dose
다른 이름들:
|
활성 비교기: ACE-650
650 mg Acetaminophen Caplet
|
Acetaminophen Caplet - single dose
다른 이름들:
|
위약 비교기: ACE-0
0 mg Acetaminophen Caplet
|
0 mg Caplet - single dose
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Overall Analgesic Efficacy - Sum of Pain Intensity Difference and Pain Relief Scores Over Six Hours (SPRID6)
기간: 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.
|
6 Hours
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Sum of Pain Intensity Difference Over Six Hours (SPID6)
기간: 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)
기간: 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.
|
6 Hours
|
Pain Intensity Difference (PID) at 15 Minutes
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
Pain Intensity Difference (PID) at 180 Minutes
기간: 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
기간: 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
기간: 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
기간: 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
|
Pain Relief (PAR) Scores at 15 Minutes
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: within 6 Hours
|
Minutes until rescue medication was given.
|
within 6 Hours
|
Rescue Rates Through Four Hours
기간: through 4 Hours
|
Percentage of subjects using rescue medication.
|
through 4 Hours
|
Rescue Rates Through Six Hours
기간: through 6 Hours
|
Percentage of subjects using rescue medication.
|
through 6 Hours
|
Percentage of Subjects With >50% of the Maximum Possible TOTPAR6 Score
기간: 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
기간: 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
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: Daniel Qi, M.D., McNeil Consumer Healthcare Division of McNEIL-PPC, Inc.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2010년 6월 1일
기본 완료 (실제)
2011년 1월 1일
연구 완료 (실제)
2011년 1월 1일
연구 등록 날짜
최초 제출
2010년 4월 30일
QC 기준을 충족하는 최초 제출
2010년 5월 3일
처음 게시됨 (추정)
2010년 5월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 5월 28일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 4월 26일
마지막으로 확인됨
2012년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ACEPAI2001
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Acetaminophen에 대한 임상 시험
-
Sun Pharma Advanced Research Company Limited완전한
-
Daewon Pharmaceutical Co., Ltd.완전한
-
Daewon Pharmaceutical Co., Ltd.완전한발치 수술 후 중등도 이상의 통증을 보이는 급성 치통 환자
-
Janssen Korea, Ltd., Korea완전한
-
Teva Branded Pharmaceutical Products R&D, Inc.Syneos Health완전한