EUCTR2012-004548-31-HU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 after elective unilateral total hip arthroplasty.
Menarini Ricerche S.p.A.0 个研究点目标入组 600 人开始时间: 2013年3月18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
- All
入选标准
- •1.Male or female patients aged 18 to 80 years. Females participating in the study must be either: of non-childbearing potential, or willing to use a highly contraceptive method.
- •2.Scheduled to undergo standard primary (first-time) one-sided total hip replacement surgery due to osteoarthritis (excluding osteoarthritis secondary to systemic/ metabolic diseases, trauma and infections) and requiring hospitalization for at least 5 days after the surgery.
- •3.ASA (American Society of Anaesthesiologists) Patient Classification Status I, II or III.
- •4.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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
排除标准
- •1.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.
- •2.Patients with clinically significant abnormalities of vital signs (VS), safety laboratory tests and 12-lead ECG at screening.
- •3.Patients with history of allergy or hypersensitivity to the study drugs, RM or to any other NSAIDs, opioids, acetyl salicylic acid, pyrazolones or pyrazolidines.
- •4.Patients with history of peptic ulcer, gastrointestinal disorders by NSAIDs or gastrointestinal bleeding or other active bleedings.
- •5.Patients with history of severe asthma.
- •6.Patients with moderate to severe renal dysfunction, severe hepatic dysfunction or severe cardiac dysfunction.
- •7.Patients with coagulation disorders.
- •8.Patients with history or current epilepsy.
- •9.Patients with Crohn’s disease or ulcerative colitis.
- •10.Patients with acute intermittent hepatic porphyria.
- •11.Patients with congenital G6PD (glucose-6-phosphate dehydro-genase) deficiency.
- •12.Patients with impaired bone marrow function (e.g. following treatment with cytostatic drugs) or haematopoiesis disorders.
- •13.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 study assessment (i.e. 8 hours after last intake of study medication).
- •14.Patients under chronic opioid treatment (major opioids and tramadol).
- •15.Patients using and not suitable for withdrawing the prohibited medication, within 48 hours or 5 half-lives (whichever is the longer) prior to the start of surgery and up to 24 hours after the last intake of study medication:
- •-Anticoagulants, thrombolytic and antiplatelet agents (except standad pri-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
- •16.Patients receiving concomitant treatment with other investigational drugs or who have participated in other clinical trial within 4 weeks before entering the study.
- •17.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).
- •18.Pregnant and breastfeeding women.
- •19.Patients experiencing any surgical complication that, in the opinion of the Investigator, advises against their inclusion in the study.
- •20.Patients experiencing any surgical complication that, in the opinion
- •of the Investigator, advises against their inclusion in the study
- •21.Patients who are exposed to ondansetron (or other 5-HT-3 receptor
- •antagonist antiemetics) on the day of randomization. NOTE: 5-HT-3
- •receptor antagonist antiemetics are prohibited from the day of
- •randomization up to completion of last study assessment (i.e. 8 hours
- •after last intake of study medication).
研究者
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