EUCTR2017-003307-21-NL进行中（未招募）1 期
Tailored treatment of functional dyspepsia with nortriptyline: a multi-center double-blind placebo-controlled trial (TENDER) - TENDER
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 154
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 with functional dyspepsia (FD), diagnosed according to the Rome IV criteria
- •- Age 18-65 years
- •- Predicted CYP2D6 extensive metabolizer phenotype on the basis of CYP genotyping
- •- In the presence of alarm symptoms, patients are required to have undergone a upper gastrointestinal endoscopy (without evidence of organic disease), and have tested negative for Helicobacter pylori 2 years prior to inclusion.
- •- Insufficient effect of first line treatment with proton pump inhibitors or prokinetics.
- •- Women in their fertile age (<55 years old) must use contraception or be postmenopausal for at least two years.
- •Patients are recruited in primary and secondary/tertiary healthcare settings.
- •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 154
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-History of gastric ulcer;
- •-Evidence of current anxiety and/or depression disorder as defined by a score = 10 on the GAD-7 and/or PHQ-9 questionnaire, supported by a detailed interview by the investigator (i.e. the investigator is required to confirm suspicion of anxiety or depressive disorder);
- •-Predicted CYP2D6 poor, intermediate or ultrarapid metabolizer phenotype on the basis of CYP genotyping
- •-Current use or any previous use of psychotropic medication in the last 3 months prior to inclusion;
- •-Inability to discontinue prokinetics*, NSAIDs or opioids;
- •- Excessive alcohol consumption, defined as > 2 of 3 units per day (females and males respectively)
- •-Using drugs of abuse;
- •- Previous major abdominal surgery or radiotherapy interfering with gastrointestinal function:
- •a.Uncomplicated appendectomy, cholecystectomy and hysterectomy allowed unless within the past 6 months;
- •b. Other surgery upon judgment of the principle investigator;
- •-History of liver disease, cholangitis, achlorhydria, gallstones or other diseases of the gallbladder/biliary system;
- •-Pregnancy or lactation.
- •- History of epilepsy
- •- History of glaucoma
- •* Patients still using prokinetics at the time of inclusion will be asked to discontinue treatment. A wash-out period of 2 weeks before the run-in period is required. Patients that cannot discontinue prokinetic therapy will be excluded. Patients on proton pump inhibitors should continue these without altering dosage, given that rebound symptoms can occur with discontinuation.
研究者
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