NL-OMON51266
已完成
4 期
The Effect of Enzalutamide on Oxycodone Metabolism in Men with Prostate Cancer - ENZYME
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Deventer Ziekenhuis
- 入组人数
- 27
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
Trial is onging in other countries
研究者
入排标准
入选标准
- •\- Males aged \>\= 18 years;
- •\- Diagnosed prostate cancer;
- •\- Treated with enzalutamide 160 mg once daily for 40 days (arm 1\)
排除标准
- •\- a body mass index (BMI) outside the range of 18 to 30 kg/m2;
- •\- known metastases in the liver that would affect drug metabolism;
- •\- Child\-Pugh classification B or C that would affect drug metabolism;
- •\- known CYP3A4 or CYP2D6 polymorphisms that would affect drug metabolism
- •(patients with a known CYP3A4 or CYP2D6 polymorphism afterwards will be
- •\- known moderate\-severe renal dysfunction (GFR \<60 ml/min/1\.73m2\) that would
- •affect drug metabolism;
- •\- gastrointestinal disorders that would potentially alter absorption;
- •\- previous gastric bypass or gastric band surgery;
- •\- known allergy, hypersensitivity or intolerance to normal\-release oxycodone;
结局指标
主要结局
未指定
相似试验
已完成
4 期
The effects of enoximone in acute exacerbation COPD: a pilot studyAcute pulmonary attackBronchospasmExacerbation COPD10024967NL-OMON49504Rijnstate Ziekenhuis4
已完成
不适用
The acute effects of oxazepam on actual driving performance and cognitive functionscognitief functionerennot applicableNL-OMON41122niversiteit Maastricht27
已完成
不适用
The full scope of oxytocinergic influences on the parental brain: Maternal defensiveness and grandparent-child interactionsAdult-child interaction, behavioral and brain responsesNot applicable10001474NL-OMON41352niversiteit Leiden10
已完成
3 期
Efficacy, safety and tolerability of lacosamide in patients with gain-of-function Nav1.7 mutations related small fiber neuropathy: a randomized, double-blind, placebo controlled, crossover trialNL-OMON41621Medisch Universitair Ziekenhuis Maastricht25
已完成
4 期
rsodeoxycholic acid for the prevention of symptomatic gallstone disease after Roux-en-Y Gastric Bypass and Sleeve Gastrectomy.NL-OMON49056Academisch Medisch Centrum985