Effect of citalopram on chest pain in patients with achalasia

Amsterdam UMC (location AMC)0 个研究点目标入组 48 人开始时间: 待定最近更新: 2024年6月11日

适应症

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•- Written informed consent
•- Minimum age: 18 years. Maximum age: 75 years.
•- Diagnosed with achalasia type 1 or 2, confirmed by high-resolution manometry
•- Previously treated with pneumodilatation, Heller’s myotomy or POEM
•- =3 months post-treatment for achalasia
•Recurrent chest pain
•o Midline chest pain or discomfort that is not of burning quality
•o At least 3 episodes per week of unexplained chest pain, for a minimum of 3 months.
•o No significant stasis, defined as <2cm stasis after 5 minutes on timed barium esophagram
•o At start of symptoms, no sign of reflux esophagitis on last esophagogastroduodenoscopy

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•- Achalasia type 3 (‘’spastic type’’) or spastic contractions on high-resolution manometry
•- Surgery of the esophagus except Heller’s myotomy and POEM
•- Currently using antidepressants
•- Chest pain suspect of cardiac origin.
•- 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 (contraindication for placebo or citalopram)

发起方

Amsterdam UMC (location AMC)