The Effect of Acute Intake of Oral Buspirone Hydrochloride on Esophageal Motility, Bolus Transit and Symptoms of Dysphagia, in Patients with Ineffective Esophageal Motility: A Pilot, Open-label, Single Dosing Study with High-Resolution Esophageal Manometry and Impedance.

uzleuven0 个研究点目标入组 0 人开始时间: 2010年6月30日最近更新: 2021年3月17日

试验速览

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•1.Age >18 and <60 years.
•2.Minimum duration of dysphagia history: 2 months.
•3.Recent esophago-gastroscopy.
•4.A baseline esophageal manometric profile with at least 30% of wet swallows exhibiting any combination of the following abnormalities: (i) non-transmitted contractions (ii) low amplitude contractions (peristaltic contractions with amplitude <30 mmHg in the distal esophagus)1 (iii) a = 2 cm defect in the 30 mm Hg isobaric contour of the distal esophageal segment.19
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.A history of allergic reaction to buspirone, or multiple allergies to several foods and drugs.
•2.Pregnancy, lactation.
•3.Concomitant administration of monomine oxidase inhibitors (MAOI), verapamil, or diltiazem, or medications affecting esophageal motility .
•4.Significant commorbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic).
•5.A demonstrable obstructive cause of dysphagia.
•6.Prior history of esophageal, ENT or gastric surgery or endoscopic antireflux procedure.
•7.A clinical and manometric diagnosis of achalasia, diffuse esophageal spasm, nutcracker esophagus, or hypertensive lower esophageal sphincter (LES).

发起方

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