NL-OMON31322已完成不适用
A, randomised, double-Blind, placebo-controlled pilot study with ibuprofen to implement the Post Surgical Dental Pain Model at the Kendle Clinical Pharmacology Unit in cooperation with Departments of Oral and Maxillofacial Surgery - Nvt
Kendle International0 个研究点目标入组 20 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Subjects must be male or female and at least 18 years of age;
- •2. Females should not be pregnant;
- •3. Subjects must voluntarily sign a written informed consent agreement approved by the Independent Ethics Committee (IEC) after explanation of the nature and objectives of the study and prior to any study specific procedure;
- •4. Subject has had surgical extraction from up to four 3rd molars of which at least one is a fully or partially impacted mandibular 3rd molar;
- •5. Subject has a baseline measurement of at least moderate pain on a 4 point Likert scale (*none*, *slight*, *moderate*, *severe pain*) and a minimum of 50 mm on a 100 mm VAS Pain Intensity Scale (*no pain* - *very severe pain*);
- •6. The subject receives the study medication within 4 hours after completion of surgery;
- •7. Subjects must otherwise be in good health, based upon the results of medical history;
- •8. Subject is awake and alert and able to complete protocol-specified assessments.
排除标准
- •1. Female subjects that are pregnant (as shown by a positive urine pregnancy test) or lactating;
- •2. Subject should not have other (c honic) pain than pain caused by the molar extraction;
- •3. Subjects with contraindication for Ibuprofen like asthma, gastrointestinal bleeding, use of anticoagulants, bleeding disorders;
- •4. Subjects with contraindication for dental surgery;
- •5. Smoking is not allowed from pre-treatment until discharge;
- •6. Treatment with short-acting analgesics (paracetamol, aspirin) within 6 hours prior to surgery, ibuprofen within 10 hours prior to surgery and/or long-acting NSAIDs (naproxen, etc) or COX-2 inhibitors within 48 hours prior to surgery. Except for preoperative en intraoperative anaesthetic, treatment with drugs that can confound the analgesic response (like tricyclic antidepressants, sedatives, tranquilizers, antihistamines) within 5 half lifes of the respective drug prior to surgery;
- •7. Subjects who receive surgical medication other than lignocain 2% (with epinep hine 1:100,000?); to be discussed
- •8. Subjects with a presence or a history of clinically relevant conditions in the gastrointestinal, hepatic, renal, urogenital, cardiovascular, metabolic, endocrine or central and peripheral nervous systems;
- •9. Subjects with active presence or history of alcoholism or drug addiction;
- •10. Subjects with positive alcohol and drugs screen;
- •11. Subjects with a relevant food or drug hypersensitivity or allergy;
- •12. Subject with intolerance to any ingredients of the placebo;
- •13. Subjects who are considered unsuitable to participate in the study for any reason in the opinion of the principal investigator;
研究者
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