Efficacy of gastrointestinal medications in patients with upper gastrointestinal symptoms -randomized, parallel group, open-label study
- Conditions
- Patients with upper gastrointestinal symptoms
- Registration Number
- JPRN-UMIN000005399
- Lead Sponsor
- Japan Dyspepsia Society
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 500
Not provided
(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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.