JPRN-jRCT2071210072Active, not recruitingPhase 2
Investigator-initiated phase II trial to evaluate the efficacy and safety of Acotiamide in patients with esophagogastric junction outflow obstruction
Ihara Eikichi0 sites42 target enrollmentStarted: October 2, 2021Last updated:
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 42
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 20age old to ot applicable (—)
- Sex
- All
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
- •11) Female patients who are pregnant, lactating, or of childbearing potential
- •12) Patients who refuse to use appropriate contraceptive methods during the study period.
- •13) Patients who are judged by the principal investigator or sub-investigator to be inappropriate for the study.
Investigators
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