EUCTR2020-002220-37-FR进行中（未招募）1 期
Comparison of the analgesic effect of a new paracetamol formulation (paracetamol UNIFLASH) for buccal use and two different doses of an oral paracetamol form controlled versus placebo in patients suffering from moderate pain due to a tooth extraction. - PARAMOUTH
ITHER Pharmaceuticals0 个研究点目标入组 404 人开始时间: 2020年9月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 404
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.Male and female patient aged from 18 years of age at the time of signing the informed consent;
- •2.Patient scheduled to undergo the removal of one third soft-tissue impacted or not-impacted mandibular molar (associated or not to an ipsilateral erupted maxillary molar) under short-acting local anaesthetic (e.g., mepivacaine or lidocaine) preoperatively;
- •3.Patient weighing > 50 kg;
- •4. Female patient of childbearing potential must be willing to use a highly efficient birth
- •control method during the study;
- •A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a
- •postmenopausal state (= 12 continuous months of amenorrhea with no identified cause other than
- •menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus).
- •The following are considered as highly effective birth control methods : Established use of oral,
- •intravaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception
- •associated with inhibition of ovulation - Established use of oral, injected, or implanted progestogen-only hormonal contraception associated with inhibition of ovulation – Intrauterine hormone-releasing system or placement of an intrauterine device – Bilateral tubal occlusion – Vasectomised partner - True abstinence [periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception].
- •5.Patient able to understand and comply with protocol requirements and instructions;
- •6.Patient covered by national healthcare insurance system or similar system, if applicable by local regulations;
- •7.Patient who has signed a written informed consent obtained prior to any study-related procedures.
- •Additional inclusion criteria after surgery (randomization):
- •1. Patients experiencing a moderate pain within 4 hours after the dental extraction, defined by a baseline pain intensity Visual Analogic Scale (VAS) score = 40 mm and = 60 mm;
- •2. Third mandibular molar extraction completed without any immediate complication, that in the opinion of the investigator, would interfere with the study conduct and/or assessments (e.g., suspected neurosensory complication, incomplete removal of tooth).
- •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 400
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1.Patient who undergoes an extraction of contralateral molar in the same procedure or a bony-impacted molar;
- •2.Patient treated by analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within the 3 days prior to the day of randomization (or within 5 times the elimination half-life whichever the longest);
- •3.Patient who received other analgesic than short-acting preoperative or intraoperative local anaesthetic agents within 12 hours before the start of the surgery or peri-operatively until randomization;
- •4.Patient with any known hypersensitivity to paracetamol, ibuprofen or ingredients contained in Investigational Medicinal Products (IMP) and Non-Investigational Medicinal Products (NIMP);
- •5.Patient with contra-indication to the alcoholic solution for medical reason (alcoholic weaning or abuse, epilepsy);
- •6.Women with positive results on a urine pregnancy test or breastfeeding women or women of childbearing potential without an effective contraception;
- •7.Patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities;
- •8.Patient with a current or chronic history of severe renal impairment;
- •9.Patient with severe heart failure (New York Heart Association (NYHA) Class IV);
- •10.Patient with history of gastrointestinal bleeding or perforation, related to previous NSAIDs therapy;
- •11.Patient with gastrointestinal haemorrhage, cerebrovascular haemorrhage or of other evolving haemorrhage;
- •12.Patient with an active, or history of recurrent peptic ulcer/haemorrhage (two or more distinct episodes of proven ulceration or bleeding);
- •13.Patient with inflammation or ulcerative disease of the oral mucosa (i.e., aphthae…);
- •14.Patient with known systemic lupus erythematosus;
- •15.Patient having developed hypersensitivity reactions, including symptoms of asthma, rhinitis, angioedema or urticaria after taking acetylsalicylic acid or other NSAIDs;
- •16.Patient with drug or alcohol abuse within 6 months before dosing with study medication;
- •Alcohol abuse is defined as the consumption of more than 90 mL of liquor or spirits or 530 mL of beer per day, for 5 consecutive days during the 6-month period. Drug abuse is defined as the use of any recreational drug for 5 consecutive days during the 6-month period.
- •17.Patient having participated in any clinical research study within the previous 30 days or 5 half-lives duration of the biological effect of the investigational product (whichever is longer);
- •18.Patient having any current dental or medical condition that could prevent safe participation in this study;
- •19.Unwillingness or inability to follow the procedures outlined in the protocol.
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