EUCTR2019-002114-38-IT进行中（未招募）1 期
Randomized, single dose, placebo-controlled, double-blind, parallel group study to evaluate the onset of pain response after administration of ketoprofen lysine salt 40 mg, in male and female subjects with acute pain after removal of a molar tooth - Ketoprofen - pain relief onset after molar extraction
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Informed consent: signed written informed consent before inclusion in the study
- •2.Sex and age: men/women, 18-70 year old inclusive
- •3.Surgery: removal of a single molar tooth (not impacted)
- •4.Post-operative pain: post-operative pain of intensity >30 and <=60 mm as measured by VAS within approximately 3 h of surgery
- •5.Willingness: willing to undergo an observation period for up to the last VAS evaluation within 3.5 h of surgery
- •6.Ability: able to complete 100-mm VAS and to use stopwatches during the observation period
- •7.Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with
- •the investigator and to comply with the requirements of the entire study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Surgery: extraction of impacted and dystopic teeth, tooth preserving operations, apically positioning flap/vestibuloplasty with free gingival graft from the palate, more than one tooth extraction in the same extraction procedure
- •2.General health: general health conditions unsuitable for a safe administration of conscious sedation to
- •out-patients
- •3.Allergy: ascertained or presumptive hypersensitivity to the active principles (ketoprofen and paracetamol as rescue medication) and/or formulations' ingredients; history of anaphylaxis to drugs (in particular to NSAIDs) or allergic reactions in general, which the investigator considers may affect the outcome of the study
- •4.Diseases: significant history of renal, hepatic, gastrointestinal (in particular, active peptic ulcer or haemorrhage, history of gastro-intestinal haemorrhages, ulcerations or perforations or chronic dyspepsia) cardiovascular with the exclusion of hypertension and coronary artery disease, haematological, endocrine with the exclusion of diabetes, autoimmune or neurological diseases that may interfere with the aim of the study. History of bronchial asthma
- •5.Medications: non-steroidal anti-inflammatory drugs, among which in particular ketoprofen, paracetamol and acetylsalicylic acid, taken in the 3 h before surgery. Slow-release analgesics taken in the 24 h before surgery
- •6.Investigative drug studies: participation in the evaluation of any investigational product for 1 month before this study or previous participation in the present study
- •7.Drug, alcohol: history of drug and/or alcohol abuse [>1 drink/day for females and >2 drinks/day for males, defined according to the USDA Dietary Guidelines 2015]
- •8.Pregnancy (women only): positive or missing pregnancy test at screening, pregnant or lactating women
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