Investigator-initiated phase II trial to evaluate the efficacy and safety of Acotiamide in patients with esophagogastric junction outflow obstruction

Ihara Eikichi0 sites42 target enrollmentOctober 2, 2021

Overview

No summary available.

Registry

who.int

Start Date

October 2, 2021

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Ihara Eikichi

•1\) Patients over the age of 20 at the time of consent.
•2\) Patients diagnosed as EGJOO by HRM according to Chicago Classification ver3\.0\.
•3\) Patients who have been experiencing sensation of food sticking in chest for at least one month prior to the time of consent, and have a score of 2 (symptomatic and slightly troubled) or higher on at least one evaluation of food sticking symptoms during the previous week of observation.
•4\) Patients who have undergone esophagogastroduodenoscopy and esophagography, and have been excluded from other organic diseases that may cause symptoms(e.g.reflux esophagitis, eosinophilic esophagitis, gastric ulcer, etc.) .
•5\) Patients who understand the contents of the clinical trial and have given written consent of their own free will.

•1\) Patients with clinically evident hepatic dysfunction (AST or ALT in the previous observation period is three times or more than the upper limit of the institutional standard range)
•2\) Patients with severe renal dysfunction or renal insufficiency (creatinine clearance of less than 30 mL/min in the previous observation period)
•3\) Patients with a history of hypersensitivity to any component of the investigational drug
•4\) Patients who have taken acotiamide orally in the month prior to obtaining consent
•5\) Patients with concomitant malignancy. However, patients with completely resected basal cell carcinoma, Stage I spinous cell carcinoma, intraepithelial carcinoma, intramucosal carcinoma, or superficial bladder cancer may be included the study.
•6\) Patients with frequent irregular dietary habits, such as not eating or binge drinking/eating.
•7\) Patients with a history of upper gastrointestinal surgery. However, surgeries related to endoscopic treatment including endoscopic polypectomy, endoscopic mucosal resection and endoscopic submucosal dissection are excluded.
•8\) Patients who have participated in other clinical trials or clinical studies, and used or are using investigational drugs, devices, or products during the 3 months prior to obtaining consent.
•9\) Patients with serious cardiac or hematological diseases.
•10\) Patients with serious drug allergies