Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
2012년 7월 12일 업데이트: Pfizer
Evaluation Of The Efficacy Of A Novel Ibuprofen Formulation In The Treatment Of Post-Surgical Dental Pain: Study I
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.
연구 개요
연구 유형
중재적
등록 (실제)
335
단계
- 3단계
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:
- 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
Exclusion Criteria:
- 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])
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: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 트리트먼트 A
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새로운 이부프로펜 1회 용량(이부프로펜 400mg과 동일)
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활성 비교기: 트리트먼트 B
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Single-dose of standard ibuprofen (400mg)
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활성 비교기: 트리트먼트 C
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Single-dose of standard ibuprofen (400mg)
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위약 비교기: Treatment D
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위약의 단일 용량
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)
기간: 0 to 8 hours
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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).
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0 to 8 hours
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Time to Onset of Meaningful Relief
기간: 0 to 8 hours
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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.
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0 to 8 hours
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to Confirmed First Perceptible Relief
기간: 0 to 8 hours
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Participants evaluated the time to first perceptible relief by stopping a stopwatch labeled 'first perceptible relief' at the moment they first began to experience any relief.
Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.
The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
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0 to 8 hours
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Pain Relief Rating (PRR)
기간: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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PRR was evaluated at different time points during the study up to 8 hours after taking the study medication, and immediately before rescue medication was taken (if necessary).
PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
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0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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Pain Intensity Difference (PID)
기간: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]).
Total possible score range for PID: -1 (worst) to 3 (best).
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0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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Sum of Pain Relief Rating and Pain Intensity Difference (PRID)
기간: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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PRID was sum of PID and PRR at each post-dosing time point.
The overall possible score range, for PRID was -1 (worst) to 7 (best).
PID was derived by subtracting the pain severity score at a given post-dosing time point (pain severity score range 0 [none] to 3 [severe]) from the baseline score (Baseline pain severity score range 2 [moderate] to 3 [severe]).
Total possible score range for PID: -1 (worst) to 3 (best).
PRR was assessed on 5-point categorical pain relief rating scale (0=No relief to 4=Complete relief).
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0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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Time-weighted Sum of Pain Intensity Difference (SPID)
기간: 0-2, 0-3, 0-6, 0-8 hours
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SPID: time-weighted sum of PID over 2, 3, 6 and 8 hours.
SPID scores range was -2 (worst) to 6 (best) for SPID 0-2, -3 (worst) to 9 (best) for SPID 0-3, -6 (worst) to 18 (best) for SPID 0-6, -8 (worst) to 24 (best) for SPID 0-8.
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).
Total score range for PID: -1(worst) to 3 (best).
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0-2, 0-3, 0-6, 0-8 hours
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Time-weighted Sum of Pain Relief Rating (TOTPAR)
기간: 0-2, 0-3, 0-6, 0-8 hours
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TOTPAR: time-weighted sum of PRR scores over 2, 3, 6 and 8 hours.
TOTPAR score range was 0 (worst) to 8 (best) for TOTPAR 0-2, 0 (worst) to 12 (best) for TOTPAR 0-3, 0 (worst) to 24 (best) for TOTPAR 0-6, 0 (worst) to 32 (best) for TOTPAR 0-8.
PRR was evaluated at different time points during the study up to 8 hours, and immediately after taking rescue medication (if necessary).
PRR was assessed on a 5-point categorical pain relief rating scale wherein 0=No relief to 4=Complete relief.
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0-2, 0-3, 0-6, 0-8 hours
|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
기간: 0-2, 0-3, 0-6, 0-8 hours
|
SPRID: time-weighted sum of PRID over 2, 3, 6 and 8 hours.
SPRID score range:-2 (worst) to 14(best) for SPRID 0-2, -3(worst) to 21(best) for SPRID 0-3, -6(worst) to 42(best) for SPRID 0-6, -8(worst) to 56(best) for SPRID 0-8.
PRID:sum of PID and PRR at each time point.
Total score range for PRID: -1=worst to 7=best.
PID:baseline pain severity score minus pain severity score at given time(score range 0=none to 3=severe; baseline score range 2=moderate to 3=severe).
Total score range for PID: -1(worst) to 3(best), PRR: scored on 5-point pain relief rating scale(0=No relief to 4=Complete relief).
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0-2, 0-3, 0-6, 0-8 hours
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Cumulative Percentage of Participants With Meaningful Relief
기간: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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Percentage of participants with meaningful relief evaluated by stopping the stopwatch labeled 'meaningful relief' at the moment the participant 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.
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0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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Cumulative Percentage of Participants With Confirmed First Perceptible Relief
기간: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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Percentage of participants with first perceptible relief was evaluated by stopping a stopwatch labeled 'first perceptible relief' at the moment the participant first began to experience any relief.
Stopwatch was active up to 8 hours after dosing or until stopped by the participant, or rescue medication was administered.
The first perceptible relief was considered confirmed if the participant also stopped the second stopwatch indicating meaningful relief.
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0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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Time to Treatment Failure
기간: 0 to 8 hours
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Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first.
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0 to 8 hours
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Cumulative Percentage of Participants With Treatment Failure
기간: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
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0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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Cumulative Percentage of Participants With Complete Relief
기간: 0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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Complete relief was defined as a PRR of 4. PRR was assessed on a 5-point categorical pain relief rating scale where 0=No relief to 4=Complete relief.
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0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
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Participant Global Evaluation of Study Medication
기간: 8 hours
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Participant global evaluation of study medication was performed at the 8-hour time point or immediately before taking the rescue medication.
It was scored on a 6-point categorical scale where 0 = Very poor, 1 = Poor, 2 = Fair, 3 = Good, 4 = Very Good, and 5 = Excellent.
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8 hours
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Jayawardena S, Leyva R, Kellstein D. Safety of a novel formulation of ibuprofen sodium compared with standard ibuprofen and placebo. Postgrad Med. 2015 Jan;127(1):33-7. doi: 10.1080/00325481.2015.993268. Epub 2014 Dec 15.
- Brain P, Leyva R, Doyle G, Kellstein D. Onset of analgesia and efficacy of ibuprofen sodium in postsurgical dental pain: a randomized, placebo-controlled study versus standard ibuprofen. Clin J Pain. 2015 May;31(5):444-50. doi: 10.1097/AJP.0000000000000142.
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 4월 1일
기본 완료 (실제)
2010년 7월 1일
연구 완료 (실제)
2010년 8월 1일
연구 등록 날짜
최초 제출
2010년 4월 1일
QC 기준을 충족하는 최초 제출
2010년 4월 1일
처음 게시됨 (추정)
2010년 4월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2012년 8월 17일
QC 기준을 충족하는 마지막 업데이트 제출
2012년 7월 12일
마지막으로 확인됨
2012년 7월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- AH-09-10
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. .
통증에 대한 임상 시험
-
Bingol UniversityAtaturk University아직 모집하지 않음수술 전 불안 | 두려움 | PAIN
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Weill Medical College of Cornell UniversityNew York University; National Center for Complementary and Integrative Health (NCCIH)모병
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Istanbul University모병Masticatory Muscle Pain | 근시 통증 증후군 (MP)칠면조
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Istanbul University모병이갈이 | 근막 통증 증후군 | Masticatory Muscle Pain | 현지 근육통터키 (Türkiye)
위약에 대한 임상 시험
-
Newish Biotech (Wuxi) Co., Ltd.아직 모집하지 않음
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Chiesi Farmaceutici S.p.A.아직 모집하지 않음
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Nature's Sunshine Products, Inc.아직 모집하지 않음
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Yale UniversityHartford HealthCare아직 모집하지 않음
-
Acesion Pharma모병
-
Shanghai Lanyi Therapeutics Co., Ltd.완전한
-
University of Texas Southwestern Medical Center아직 모집하지 않음
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Universidad Autonoma de Zacatecas모집하지 않고 적극적으로
-
University of California, San Francisco아직 모집하지 않음