Myasthenia Gravis
Conditions
Interventions
Acotiamide should be administered orally, one 100 mg tablet three times a day before meals. Placebo will be administered in the same manner. The dosing period will consist of 28 consecutive days of a
Sponsors
Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients diagnosed with myasthenia gravis Patients with one or more symptoms of dysphagia, postprandial bloating, early satiety, upper abdominal pain, or upper abdominal discomfort for at least 6 months prior to obtaining consent Patients who have undergone upper gastrointestinal endoscopy within 6 months of obtaining consent and no lesions causing gastrointestinal symptoms were found. Patients who have not used acotiamide within 3 months of obtaining consent Patients who are at least 18 years old and able to understand and consent to the study by themselves.
Exclusion criteria
Exclusion criteria: Patients under 18 years of age at the start of treatment Patients with obvious organic disease as a possible cause of dysphagia, postprandial bloating, early satiety, epigastric pain, or epigastric discomfort. Patients with acothiaminergic allergies Patients who are allergic to acotiamide. Other patients whose inclusion in the study is deemed inappropriate by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Superiority of the rate of improvement of dyspepsia symptoms with acotiamide over placebo during the first 4 weeks of oral administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Superiority of the rate of improvement of dyspepsia symptoms with acotiamide over placebo at weeks 1, 2, and 3 after initiation of oral therapy. Incidence of adverse effects and change in MG symptoms with acofide (MG-ADL, MG-QOL, MG composite) | — |
Countries
Japan
Contacts
Public ContactHideki Mori
Keio University School of Medicine Division of Gastroenterology and Hepatology, Department of Internal Medicine
Outcome results
None listed