NL-OMON52924招募中3 期
Tailored treatment of functional dyspepsia with nortriptyline: a multi-center double-blind placebo-controlled trial (TENDER) - TENDER
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 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
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •- Patients with functional dyspepsia (FD), diagnosed according to the Rome IV
- •- Age 18-65 years
- •- Predicted CYP2D6 extensive metabolizer phenotype on the basis of CYP
- •- 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.
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 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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