Acetaminophen's Antinociceptive Effect When Associated With N-Acetylcysteneine (PANACE)
ACETAMINOPHEN ANTINOCICEPTIVE EFFECT WHEN ASSOCIATED WITH N-ACETYLCYSTENEINE
Acetaminophen is one of the most widely used analgesic in the world, recommended for the symptomatic treatment of fever and pain.
The purpose of this study is to assess the effectiveness of acetaminophen in association with N-acetylcysteine.
The objective of this study is to evaluate if the association in healthy volunteers of acetaminophen and N-acétylcystéine
- - decrease the antinociceptive effect of acetaminophen in comparison to a group control
- - and if this antinociceptive effect may depend of the genetic polymorphism of GSH enzyme.
調査の概要
詳細な説明
Period 1 : To Day -4 to Day 0
Day -4 at 8:00 am at Clinical Pharmacology Center
- Inclusion Visit, signature of Informed consent form, clinical exam.
- Training test
- Blood sample (GSH, pharmacogenetic, Biochemistry assay)
- Randomization and attribution of treatment for the fisrt study period at home: (day -4, -3, -2, -1) 4 days of oral acetaminophen and [N-acetylcysteine or placebo] according to the randomization plan.
At day -3, -2 and -1 a salivary sample will be done to control the treatment compliance.
Day 0 at Clinical Pharmacology Center Clinical examination Measurement of the basal pain thresholds and pain evaluation (Visual Analog Scales) Blood and urinary sample (acetaminophen and GSH assay)
T0 : Administration of product: acetaminophen and [N-acetylcysteine or placebo]
T0+1H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales)
T0+2H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales) and Blood sample (acetaminophen assay)
T0+3H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales)
T0+4H: Thermal stimulation according to the established paradigm (threshold temperature +3°C ) and pain evaluation (Visual Analog Scales) and Blood and urinary sample (acetaminophen, GSH, biochemistry assay)
- Lunch before departure
2 weeks of wash-out
Period 2 : To Day 17 to Day 21
Same of period 1. Subject who receives N-acétylcystéine in period 1 will receive placebo in second period and vice versa.
研究の種類
入学 (実際)
段階
- フェーズ 1
連絡先と場所
研究場所
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Clermont-Ferrand、フランス、63003
- CHU de Clermont-Ferrand
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Male
- Between 18 and 45 years old
- Without treatment during the 7 days before inclusion specially no use of antalgic and anti-inflammatory
- Cooperation and understanding enough to conform to the study obligations -Having given free, informed written consent
- Affiliated at system of French social security
- Inscription or acceptation of inscription in the national register of volunteers involved in trials.
Exclusion Criteria:
- Patient with one or many contraindication for the administration of the trial's products,
- Patient that have taken N-acetylcysteine as bronchial thinner during the last 3 days,
- Patient with medical or surgical history judged by the investigator or his representative as being not compatible with the clinical trial
- Patient with disease progression during inclusion,
- Patient with excessive consumption of alcohol, tobacco (+ than 10 cigarette/day), coffee, tea or drinks with caffeine (equivalent to more than 4 cup a day) or any addiction to drugs,
- Patient with a heat pain mean threshold during training higher or equal to 46.5°C,
- Patient who participated in another clinical trial, located in exclusion period or received benefits > 4500 euros during 12 months before the beginning of trial,
- Patient with cooperation and understanding that do not allow him to follow the trial,
- Patients with minor or under guardianship,
- No affiliation at system of French social security
研究計画
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：クロスオーバー割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：acetaminophen
The purpose of this study is to assess the effectiveness of acetaminophen in association with N-acetylcysteine. The objective of this study is to evaluate if the association in healthy volunteers of acetaminophen and N-acétylcystéine
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プラセボコンパレーター：placebo
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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 |
|---|---|---|
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Pain intensity using Visual Analog Scales (VAS) succeeding thermic stimulations at the threshold temperature +3°C before (T0-1h) and after acetaminophen's administration
時間枠：At day 0
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Pain intensity using Visual Analog Scales (VAS) succeeding thermic stimulations at the threshold temperature +3°C before (T0-1h) and after acetaminophen's administration (T0+1h, T0+2h, T0+3h, T0+4h).
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At day 0
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Blood glutathione GSH concentration
時間枠：At day 0
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Blood glutathione GSH concentration at J0 T0-1h and J0 T0+4h
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At day 0
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Blood of acetaminophen concentration and its metabolites
時間枠：at day 0
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Blood of acetaminophen concentration and its metabolites at J0 T0-1h, T0+2h, and T0+4h.
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at day 0
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Urinary assay of the rate of acetaminophen and its metabolites
時間枠：at day 0
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Urinary assay of the rate of acetaminophen and its metabolites at J0 T0-1h, and T0+4h.
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at day 0
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Pharmacogenetic dosage of enzymes involved in glutathione metabolism
時間枠：at day 4
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at day 4
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協力者と研究者
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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。
プラセボの臨床試験
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Shanghai Hengrui Pharmaceutical Co., Ltd.完了
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Consano Bio募集坐骨神経痛 | 坐骨神経根症 | 腰仙神経根症 | 腰仙神経根症候群 | 腰仙部神経根痛 | 坐骨神経痛オーストラリア
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Palacky University完了