EUCTR2020-002245-42-FR进行中（未招募）1 期
A Comparative, Randomized, Double-blind, 3-arm parallel, Phase III Study to Evaluate the Efficacy and Safety of a Fixed Dose Combination of Nefopam/Paracetamol (tablet) Taken Orally in Moderate to Severe Pain After Impacted Third Molar Extraction - METAPAI
ITHER Pharmaceuticals0 个研究点目标入组 321 人开始时间: 2020年8月21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
- 321
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 up to 65 years at the time of signing the informed consent,
- •2. Patient scheduled to undergo the surgical removal of at least one fully or partially impacted third mandibular molar requiring bone removal under short-acting local anaesthetic (mepivacaine or lidocaine) with or without vasoconstrictor,
- •3. Patient weighing > 50 kg,
- •4. Female patient of childbearing potential must be willing to use an efficient birth control method during the study,
- •5. Patient able to swallow the IMP (capsule length 19.05 mm and width 9.39 mm),
- •6. Patient able to understand and comply with protocol requirements and instructions, including recording of verbal rating scale (VRS) on the electronic diary (e-Diary) as required by protocol,
- •7. Patient covered by national healthcare insurance system or similar system, if applicable by local regulations,
- •8. Patient who has signed a written informed consent prior to any study-related procedures.
- •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 311
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Patient treated by analgesics or nonsteroidal anti-inflammatory drugs (NSAIDs) within 3 days preceding the day of randomization or within 5 times the elimination half-life whichever the longest,
- •2. Woman with positive results on a urine pregnancy test or breastfeeding woman or woman of childbearing potential without an effective contraception,
- •3. Patient with a history of convulsive disorders,
- •4. Patient taking mono-amine-oxidase (MAO) inhibitors (including but not limited to selegiline, isocarboxazid, tranylcypromine, phenelzine…),
- •5. Patient with an abnormal cardiac condition: medically significant disorders of cardiac rate and/or rhythm,
- •6. Patient with known anaemia,
- •7. Patient with known pulmonary disease,
- •8. Patient with known active gastric or duodenal ulcer or a history of recurrent gastrointestinal ulcer/bleeding,
- •9. Patient with known glaucoma,
- •10. Patients with a prostatic hyperplasia or urinary retention,
- •11. Patient with any known hypersensitivity to nefopam, paracetamol, ibuprofen or ingredients contained in IMPs and Non-Investigational Medicinal Product (NIMP),
- •12. Patient with current or chronic history of liver disease, or known hepatic or biliary abnormalities,
- •13. Patient with a current or chronic history of severe renal impairment (glomerular filtration below 30 mL/min),
- •14. Patient having developed hypersensitivity reactions, including symptoms of asthma, rhinitis or urticaria after taking acetylsalicylic acid or other NSAIDs,
- •15. Patient with known systemic lupus erythematosus,
- •16. Patient with drug or alcohol abuse within 6 months before dosing with study medication,
- •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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