EUCTR2005-001791-13-DE进行中（未招募）不适用
An open-label, randomized, parallel-group, monocenter study to evaluate safety and efficacy of Oxycodone Hydrochloride administered orally (CR) and intravenously in patients with total hip endoprosthesis in comparison to total hip endoprosthesis patients with additional oral (CR) Oxycodone Hydrochloride premedication.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Patients (males and females) designated for total hip endoprosthesis.
- •Males and females aged 18 years and older (females less than one year post-menopausal must have a negative serum pregnancy test, be non-lactating and willing to use adequate and reliable contraception throughout the study. Highly effective methods of birth control with a failure rate less than 1% per year are such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner.).
- •Patients have to understand protocol requirements and are willing and able to fulfill them.
- •Patients must be able to understand the patient information sheet (PIS) and have provided written informed consent of study participation and concerning data protection.
- •Patients have to be willing and able to complete questionnaires.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Other opioid treatment beside study medication.
- •Clinically significant respiratory disease, cardiac disease, dysfunction of the biliary tract, thy-roid disease, adrenal cortical insufficiency, prostatic hypertrophy or renal stricture or any other medical condition, that, in the opinion of the investigator, precludes entry into this study.
- •Laboratory findings of impaired liver function (i.e. nlt 3 x ULN for AST or ALT or increasing AST/ALT as indication of liver impairment), or, in the opinion of the investigator, liver function impairment to the extent that the patient should not participate in this study.
- •Indication of impaired kidney function (i.e. nlt 1,5 x ULN for serum creatinine).
- •Depression or other psychiatric disorder such that participation in the study may, in the opin-ion of the investigator, pose an unacceptable risk to the patient.
- •Seizures or convulsive disorder requiring concomitant anticonvulsant therapy.
- •Known hypersensitivity (allergic reaction) to oxycodone hydrochloride or diclofenac colestyramine.
- •Patients with porphyria.
- •Patients with gastro-intestinal ulceration.
- •Patients with dyshaematopoiesis of unknown origin.
- •Patients with systemic lupus erythematosus.
- •Patients suffering from Morbus Parkinson.
- •Patients with history of paralytic ileus.
- •Patients with current acute pancreatitis.
- •Past or current substance or alcohol abuse, or patients who, in the opinion of the investigator, have demonstrated addictive or substance abuse behaviors.
- •Patients who have participated in another clinical trial within 12 weeks before start of this trial or who currently participate in one.
研究者
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