Study Evaluating A Novel Ibuprofen Formulation In The Treatment Of Dental Pain
2012年7月12日 更新者：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.
調査の概要
研究の種類
介入
入学 (実際)
335
段階
- フェーズ 3
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
16年～40年 (子、大人)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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])
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：治療A
|
新規イブプロフェンの単回投与（イブプロフェン 400 mg に相当）
|
|
アクティブコンパレータ：治療B
|
Single-dose of standard ibuprofen (400mg)
|
|
アクティブコンパレータ：治療C
|
Single-dose of standard ibuprofen (400mg)
|
|
プラセボコンパレーター：Treatment D
|
プラセボの単回投与
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference From 0-8 Hours (SPRID 0-8)
時間枠：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).
|
0 to 8 hours
|
|
Time to Onset of Meaningful Relief
時間枠：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.
|
0 to 8 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time to Confirmed First Perceptible Relief
時間枠：0 to 8 hours
|
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.
|
0 to 8 hours
|
|
Pain Relief Rating (PRR)
時間枠：0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
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.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
|
Pain Intensity Difference (PID)
時間枠：0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
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).
|
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)
時間枠：0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
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).
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
|
Time-weighted Sum of Pain Intensity Difference (SPID)
時間枠：0-2, 0-3, 0-6, 0-8 hours
|
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).
|
0-2, 0-3, 0-6, 0-8 hours
|
|
Time-weighted Sum of Pain Relief Rating (TOTPAR)
時間枠：0-2, 0-3, 0-6, 0-8 hours
|
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.
|
0-2, 0-3, 0-6, 0-8 hours
|
|
Time-weighted Sum of Pain Relief Rating and Pain Intensity Difference (SPRID)
時間枠：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).
|
0-2, 0-3, 0-6, 0-8 hours
|
|
Cumulative Percentage of Participants With Meaningful Relief
時間枠：0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
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.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
|
Cumulative Percentage of Participants With Confirmed First Perceptible Relief
時間枠：0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
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.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
|
Time to Treatment Failure
時間枠：0 to 8 hours
|
Median time of dropping out of the participants from the study due to lack of efficacy or rescue medication, whichever came first.
|
0 to 8 hours
|
|
Cumulative Percentage of Participants With Treatment Failure
時間枠：0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
Percentage of participants who withdrew from the study due to lack of efficacy or received rescue medication.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
|
Cumulative Percentage of Participants With Complete Relief
時間枠：0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
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.
|
0.25, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 7, 8 hours
|
|
Participant Global Evaluation of Study Medication
時間枠：8 hours
|
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.
|
8 hours
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
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出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年4月1日
一次修了 (実際)
2010年7月1日
研究の完了 (実際)
2010年8月1日
試験登録日
最初に提出
2010年4月1日
QC基準を満たした最初の提出物
2010年4月1日
最初の投稿 (見積もり)
2010年4月5日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年8月17日
QC基準を満たした最後の更新が送信されました
2012年7月12日
最終確認日
2012年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- AH-09-10
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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