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临床试验/NL-OMON38685
NL-OMON38685已完成3 期

Effect of amitriptyline in functional heartburn - amitriptyline and heartburn

Academisch Medisch Centrum0 个研究点目标入组 25 人开始时间: 待定最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
25

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 99(—)

入选标准

  • * Minimum age: 18 years
  • * Documented functional heartburn
  • * Negative esophagogastroduodenoscopy and no history of reflux esophagitis
  • * Negative 24h pH/impedance recording (physiological acid exposure time) and negative symptom association probability

排除标准

  • * Surgery of the esophagus
  • * Motility disorders of the GI tract leading to delayed gastric emptying or altered intestinal motility
  • * Use of any medication with a potential effect on upper gastrointestinal motility and/or sensitivity that can not be stopped for the duration of the study. If this medication can be stopped, it should be discontinued for at least 2 weeks before the start of the study.
  • * Severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders)
  • * Pregnancy or lactation. A pregnancy test will be carried out prior to inclusion in the study. Female patients who are premenopausal and have a negative pregnancy test should be on an anticonceptive.;* Medication-related
  • * Contra-indications for amitriptyline use: epilepsy, organic central nervous system disorders, prostate hypertrophy, pyloric stenosis, cardiovascular disease, hyperthyroidism, liver- and kidney function impairment.
  • * Interaction can occur with barbiturates, carbamazepine, ketoconazol and ritonavir . Concommitant use of MAO-inhibitors is contra-indicated.
  • * Hypersensitivity to the active substance or to any of the excipients.

研究者

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Effect of amitriptyline in functional heartbur | 临床试验