Effect of ONO-8539 on acid-induced heartburn symptom in healthy volunteers
Phase 1
Recruiting
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Registration Number
- JPRN-UMIN000015753
- Lead Sponsor
- Hyogo College of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
1. Subjects who undergo upper gastrointestinal endoscopy and are found to have significant organic diseases (e.g., esophagitis, Barrett's esophagus, hiatus hernia, active peptic ulcer disease, and esophageal/gastric cancer) 2. Subjects with history of peptic ulcer or upper GI tract surgery 3. Subjects with significant cardiovascular, kidney, liver, neurotic, or psychological disorders 4. Subjects diagnosed with GERD by questionnaire 5. Subjects taking medications that may affect prostaglandin generation, including NSAIDs, COX-2 inhibitors, or prostaglandin-containing medications 6. Individuals judged by investigators as ineligible for study enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in heartburn symptom score during acid perfusion test
- Secondary Outcome Measures
Name Time Method