Functional dyspepsia
Conditions
Interventions
Two tablets of the study drug (Masapride) taken orally three times a day before meals for 4 weeks (a total of 168 tablets)
Two tablets of the reference drug (placebo) taken orally three times a day be
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Outpatients who are at least 20 years of age. 2. Patients with at least one of the following symptoms. -Painful heavy feeling in the stomach after eating a normal amount of food that occurs at least twice a week. -Unable to finish a normal amount of food due to early satiety at least twice a week. 3. Patients with symptom onset at least 6 months before the visit who meet the above criteria 2 over the last 3 months. 4. Patients who undergo upper gastrointestinal endoscopy within 1 year from the visit and are found to have no organic diseases (malignant tumors, peptic ulcer, esophagitis, etc.) that are likely to cause upper abdominal symptoms. 5. Patients who are not receiving the following drugs or patients who can have a washout period of the drugs for at least 2 weeks before administration of the study drug if they are receiving the drugs: prokinetic agents, gastric acid secretion inhibitors (H2-receptor antagonists, proton-pump inhibitors), gastric coating agents, prostaglandin preparations, antidepressants, anti-anxiety agents, sleep-inducing drugs, antipsychotic drugs 6. Patients who are willing to comply with medication instructions. 7. Patients who can understand the requirements of the study and provide written informed consent to participate.
Exclusion criteria
Exclusion criteria: 1. Patients with conditions that are likely to cause upper abdominal symptoms such as malignant tumors, peptic ulcers and systemic diseases (neurological diseases including Parkinson's disease, metabolic diseases including diabetes, etc). 2. Patients with known causes of upper abdominal symptoms including excessive drinking, overeating, taking NSAIDs, and sever stress. 3. Patients with predominant GERD 4. Patients with predominant irritable bowel syndrome (IBS) 5. Patients with a history of surgery of the upper gastrointestinal tract including the stomach and esophagus. 6. Patients with severe hepatic dysfunction or renal dysfunction. 7. Patients with confirmed or suspected mental disorders. 8. Women who are pregnant or who wish to be pregnant during the study period, and lactating mother. 9. Other patients whom the investigator deems unsuitable for the study. 10. Patients who received H. pylori eradication therapy within 6 months from the visit or patients who are receiving the eradication therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Score for overall treatment efficacy (OTE) after 4 weeks of treatment with the study drug Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in OTE score Changes in response rate Evaluation scores by symptoms Disappearance rate of each symptom Disappearance rate of all symptoms SF-8 score Incidence of adverse events/adverse effects | — |
Countries
Japan
Contacts
Public ContactHiroto Miwa
Hyogo College of Medicine Department of Gastroenterology
Outcome results
None listed