Patients with upper gastrointestinal symptoms
Conditions
Interventions
Omeprazole 10mg orally once daily
Famotidine 10mg twice daily
Mosapride 5mg three times daily
Teprenone 50mg three times daily
Sponsors
Japan Dyspepsia Society
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Patients who have chronic or recurrent episodes of at least one of specific upper GI symptoms, such as heartburn, regurgitation, epigastric pain, postprandial fullness, nausea/vomiting, belching, early satiety and/or bloating, and endoscopically uninvestigated in the past three months. (2) Patients who have one or more of the symptoms being of at least moderate severity (Global Overall Symptom score [GOS] >= 4) in the previous week. (3) Male or female aged 20 to 65 years. (4) Patients who have freely given written consent to participating in the study after receiving a full explanation (written and oral) of the study.
Exclusion criteria
Exclusion criteria: (1) Patients who have alarm symptoms, such as vomiting, gastrointestinal bleeding or acute weight loss requiring endoscopy. (2) Patients who are judged by the investigator to require a prompt endoscopy. (3) Patients who have a confirmed or suspected malignant lesion. (4) Patients who have prior gastrointestinal resection or vagotomy. (5) Patients with irritable bowel syndrome. (6) PPIs, H2-receptor antagonists, prokinetic agents, gastric mucosal protective agents, anticholinergics, antidepressants, anxiolytics, steroids (other than topical steroids), non-steroidal anti-inflammatory drugs, aspirin or bisphosphonates were discontinued at least 1 week before study entry and were not allowed during the study period. (7) Patients who are judged to be ineligible for study entry due to serious hepatic, renal, or cardiac disease. (8) Patients who might possibly be pregnant or were lactating. (9) Patients who are judged to be ineligible for study entry by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is to compare the proportion of patients with sufficient overall symptom relief of their upper gastrointestinal symptoms after 4 weeks of treatment for all symptoms with omeprazole, famotidine, mosapride or teprenone. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are as follows: (1) To compare the proportion of patients with complete overall symptom relief of their upper gastrointestinal symptoms after 4 weeks of treatment for all symptoms with omeprazole, famotidine, mosapride or teprenone. (2) To compare the proportion of patients with sufficient overall symptom relief after 2 weeks of treatment for all symptoms with omeprazole, famotidine, mosapride or teprenone. (3) To compare the proportion of patients with sufficient overall symptom relief after 4 weeks of treatment for each symptom, such as heartburn with omeprazole, famotidine, mosapride or teprenone. (4) To examine demographic and clinical characteristics and their association with sufficient overall symptom relief on multivariate logistic regression analysis. | — |
Countries
Japan
Contacts
Public ContactYasunori Kato
Japan Dyspepsia Society Support Center Mebix, Inc, Clinical Research
Outcome results
None listed