NL-OMON38685已完成3 期
Effect of amitriptyline in functional heartburn - amitriptyline and heartburn
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.
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