EUCTR2015-004152-22-GB进行中（未招募）1 期
Analgesic efficacy of oral dexketoprofen trometamol/tramadol hydrochloride versus tramadol hydrochloride/paracetamol: a randomised, double-blind, placebo and active-controlled, parallel group study in moderate to severe acute pain after removal of impacted lower third molar. - Dexketoprofen Analgesic eVolution wIth tramaDol - DAVID study
MENARINI RICERCHE S.p.A.0 个研究点目标入组 654 人开始时间: 2015年12月18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
- 654
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
入选标准
- •1. Properly executed written informed consent.
- •2. Male or female patients aged more than 18 years.
- •3. Scheduled for outpatient surgical extraction -under local anaesthesia (i.e. 2% lidocaine with 1:80,000 epinephrine) - of lower third molar teeth, with at least one of which fully or partially impacted in the mandible requiring bone manipulation (e.g. level B or C plus class II or III of the Pell-Gregory scale).
- •4. Females participating in the study must be either:
- •- Females of non-childbearing potential, defined as any woman
- •who had undergone surgical sterilization or is more than 2 years post-menopausal;
- •- Females of childbearing potential provided that they have a negative pregnancy test at baseline (screening and qualification period) and are routinely using an effective method of birth control resulting in a low failure rate (i.e. hormonal
- •contraception, intrauterine device, condoms in combination with a spermicidal cream, male partner sterilization –vasectomy– or total sexual abstinence).
- •5. Mentally competent, able to understand and give written informed
- •consent prior to study entry.
- •6. Compliant to undergo all visits and procedures scheduled in the study, including recording of pain assessments on the electronic diary (e-Diary) as required by protocol. After surgery, patients will be eligible to progress with randomisation
- •ONLY if the following criterion is also met:
- •7. Pain of at least moderate intensity in the first 4 hours after the end of surgery (NRS score >= 4).
- •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 630
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Patients who are judged by the Investigator not to be suitable candidates for the study treatments and the RM based on their medical history, physical examination, concomitant medication (CM) and concurrent systemic diseases.
- •2. Clinically significant abnormalities in the vital signs (VS) and / or safety laboratory tests, as per investigator’s judgement.
- •3. History of allergy or hypersensitivity to the study treatments, RM or to any other NSAIDs, opioids and acetyl salicylic acid.
- •4. History of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings.
- •5. History of severe asthma.
- •6. Moderate to severe renal dysfunction, severe hepatic dysfunction or severe cardiac dysfunction.
- •7. Coagulation disorders.
- •8. History of, or current epilepsy.
- •9. Patients with Crohn’s disease or ulcerative colitis.
- •10. Patients using and not suitable for withdrawing analgesics within 12 hours before surgery (5 days prior to the surgery day in case of COX-2 inhibitors) and for 8 hours post-dose [analgesics other than those specified in the protocol (namely study treatments and RM)].
- •11. Patients using and not suitable for withdrawing alcohol, sedatives (e.g. benzodiazepines) and hypnotic agents within 12 hours before surgery and for 8 hours post-dose.
- •12. Chronic opioid treatment (major opioids and tramadol).
- •13. Patients using and not suitable for withdrawing the following prohibited medications, within 48 hours or 5 half-lives (whichever the longer) prior to the start of surgery and for 24 hours post-dose:
- •- Anticoagulants, thrombolytic and antiplatelet agents
- •- Corticosteroids (with the exception of inhalers or topical agents);
- •- Monoamine oxidase (MAO) inhibitors (a minimum of 14 days must elapse prior to the start of surgery);
- •- Antiepileptics;
- •- Antipsychotics;
- •- Serotonin reuptake inhibitors and tricyclic antidepressants;
- •- Lithium;
- •- Methotrexate;
- •- Antibacterial sulfonamides.
- •14. Participation in other clinical studies in the previous 4 weeks.
- •15. History of drug or alcohol abuse. For the purpose of the study, alcohol abuse is defined as regularly intake of more than 4 units of alcohol per day (1 unit corresponds approximately to 125 ml wine, 200 ml beer, 25 ml spirit).
- •16. History of any illness or condition that, in the opinion of the Investigator might pose a risk to the patient or confound the efficacy and safety results of the study.
- •17. Pregnant and breastfeeding women. NOTE: a pregnancy test will be performed to all women of childbearing potential at Screening and another one on the day of surgery prior to randomisation.
- •After surgery, patients will not be eligible to progress with randomisation if the following criterion is also met:
- •18. Surgical complication that, in the opinion of the Investigator, advises against their inclusion in the study.
研究者
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