EUCTR2012-004545-32-RO进行中（未招募）不适用
A randomized, double-blind, placebo and active-controlled, parallel-group study to evaluate the analgesic efficacy and safety of dexketoprofen trometamol and tramadol hydrochloride oral fixed combination on moderate to severe acute pain following abdominal hysterectomy
Menarini Ricerche S.p.A.0 个研究点目标入组 600 人开始时间: 2014年7月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 600
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
- Female
入选标准
- •1.Female patients aged 18 to 75 years.
- •2.Scheduled to undergo a total or subtotal abdominal hysterectomy (with or without salpingo-oophorectomy) for benign conditions, requiring an infraumbilical laparotomy of = 3 cm (either longitudinal or transverse) and hospitalization for at least 3 days after the surgery.
- •3.Mentally competent, able to understand and give written informed consent prior to study entry. Compliant to undergo all visits and procedures scheduled in the study, including recording of pain assessment on the electronic diary (e-Diary) as required by protocol.
- •4.ASA (American Society of Anaesthesiologists) Patient Classification Status I, II or III.
- •5.Patients experiencing pain at rest of at least moderate intensity (PI-VAS = 40 mm) the day after surgery, who are capable of swallowing oral medication and suitable to be randomized and dosed by 10:00 a.m.
- •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 200
排除标准
- •1.Patients undergoing laparoscopic surgery or supraumbilical laparotomy.
- •2.Patients who are judged by the Investigator not to be suitable candidates for study treatments and RM based on their medical history, physical examination, concomitant medication (CM) and concurrent systemic diseases.
- •3.Patients with clinically significant abnormalities of vital signs (VS), safety laboratory tests and 12-lead ECG at screening.
- •4.Patients with history of allergy or hypersensitivity to the study drugs, RM or to any other NSAIDs, opioids, acetyl salicylic acid, pyrazolones or pyrazolidines.
- •5.Patients with history of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings.
- •6.Patients with history of severe asthma.
- •7.Patients with moderate to severe renal dysfunction, severe hepatic dysfunction or severe cardiac dysfunction
- •8.Patients with coagulation disorders.
- •9.Patients with history or current epilepsy.
- •10.Patients with Crohn’s disease or ulcerative colitis.
- •11.Patients with acute intermittent hepatic porphyria.
- •12.Patients with congenital G6PD (glucose-6-phosphate dehydrogenase) deficiency.
- •13.Patients with impaired bone marrow function (e.g. following treatment with cytostatic drugs) or haematopoiesis disorders.
- •14.Patients using and not suitable for withdrawing analgesics, other than those specified in the protocol, from the end of surgery (5 days before surgery in case of COX-2 inhibitors) up to completion of last pain assessment (i.e. 8 hours after last intake of study medication). NOTE: paracetamol 500mg as antipyretic agent might be used only when strictly necessary; however, it is not allowed within the 6 hours prior to randomization and during the single-dose phase, until completion of the 8 hours post-dose assessment.
- •15.Patients under chronic opioid treatment (major opioids and tramadol).
- •16.Patients using and not suitable for withdrawing the following prohibited medication, within 48 hours or 5 half-lives (whichever is the longer) prior to the start of surgery up to 24 hours after the last intake of study medication:
- •-Anticoagulants, thrombolytic and antiplatelet agents (except standard peri-operative use for thrombo-embolic prophylaxis and = 325 mg aspirin for cardiovascular prophylaxis);
- •-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;
- •- Methotrexate;
- •- Antibacterial sulfonamides
- •17.Patients receiving concomitant treatment with other investigational drugs or who have participated in other clinical trial within 4 weeks before entering the study.
- •18.Patients with 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).
- •19.Patients with a 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.
- •20.Breastfeeding women.
- •21.Patients experiencing any surgical complication that, in the opinion of the Investigator, advises against their inclusion in the study.
- •22.Patients who are exposed to ondansetron (or other 5-HT-3 receptor antagonist antiemetics) on the da
研究者
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