CiPA Trial: Effect of Citalopram on chest pain in patients with achalasia - CiPA

Amsterdam UMC0 个研究点目标入组 68 人开始时间: 2019年4月18日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•Written informed consent
•Minimum age: 18 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
•oMidline chest pain or discomfort that is not of burning quality
•oAt least 3 episodes per week of unexplained chest pain, for a minimum of 3 months.
•oNo significant stasis, defined as <2cm stasis after 5 minutes on timed barium esophagram
•oAt start of symptoms, no sign of reflux esophagitis on last esophagogastroduodenoscopy
•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 68
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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: Allergy to barium sulfate or contra-indications for citalopram use

发起方

Amsterdam UMC