EUCTR2013-000759-41-IT进行中（未招募）不适用
A prospective, open-label, single center, cross-over, controlled, randomized, phase III study to test superiority of the oral solution of synthetic thyroxine compared to tablet preparation for treatment of hypothyrod patients under chronic gastric pump inhibitors treatment - THYLITABOR
适应症
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
- 30
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) Age range: 20-80 years,
- •2) first diagnosis of primary hypothyroidism,
- •3) chronic consumption of of PPI (ATC A02BC) for at least 3 month before enrolment,
- •4) signed informed consent
- •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 27
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1) amiodarone treatment;
- •2) presence of decompensated diabetes (glycated Hb A1c >8%);
- •3) severe liver (i.e. transaminases SGOT/SGPT > 100 U/l and/or gamma GT > 150 U/l) and renal disease (i.e. creatinine > 2 mg/dl);
- •4) active neoplastic disease including thyroid cancer;
- •5) documented active bacterium pylori gastritis;
- •6) concomitant use of other already know drugs able to interfere L-T4 absorption (Sucralfate, Aluminum containing antacids, Bile acid sequestrants, Calcium carbonate, Raloxifene);
- •7) pregnant or breast-feeding women
- •8) mental incapability to sign informed consent
研究者
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