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

JRCT ID: jRCT2071210072

Registered date:02/10/2021

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Esophageal Gastric Junction Outflow Obstruction
• Date of first enrollment: 15/10/2021
• Target sample size: 42
• Study type: Interventional
• Intervention(s): Therapeutic intervention by oral medication(Treatment Period 1:acotiamide 300 mg per day or 600 mg per day or placebo, Treatment Period 2:acotiamide 600 mg per day) is carried out after baseline screening. The safety is confirmed after the end of therapeutic intervention.

Outcome(s)

• Primary Outcome: The proportion of patients with improvement in sensation of food sticking in chest at 4 weeks in treatment period 1

Secondary Outcome

<1>The following items at 4 weeks of Treatment Period 1
1) Rate of normalization of IRP by HRM from baseline
2) Change from baseline in the score of patients with improvement in sensation of food sticking in chest
3) Change in EGJOO scale score from baseline (total score, each score)
4) Change in Gastrointestinal Symptom Rating Scale (GSRS) score from baseline (total score, subscale score)
5) Amount of change in following parameters by HRM
i)Distal Contractile Integral (DCI)
ii)Basal Lower esophageal sphincter pressure(BLESP)

<2>Correlation of IRP with sensation of food sticking in chest, EGJOO scale (total score, each score), and GSRS (total score, subscale score) at 4 weeks in Treatment Period 1 and Treatment Period 2

<3>Proportion of adverse events, adverse drug reactions

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Ihara Eikichi
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development (AMED)