Gastroesophageal Reflux Disease (GERD)
Conditions
Interventions
Diclofenac sodium is given at 6 h and 2 h before the acid perfusion test ->
Placebo is given at 6 h and 2 h before the acid perfusion test
Placebo is given at 6 h and 2 h before the acid perfusion test ->
Diclofenac sodium is given at 6 h and 2 h before the acid perfusion test
Sponsors
Hyogo College of Medicine
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Healthy male subjects 2. Sufficient informed consent is obtained
Exclusion criteria
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 medical history of asthma or allergy to NSAIDs 3. Subjects with history of peptic ulcer or GERD or of upper GI tract surgery 4. Subjects with significant cardiovascular, kidney, liver, neurotic, or psychological disorders 5. Subjects with FSSG total score of >8 6. Subjects taking medications that may affect prostaglandin generation, including NSAIDs, COX-2 inhibitors, or prostaglandin-containing medications 7. Individuals judged by investigators as ineligible for study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in heartburn symptom score (APSS) during acid perfusion test | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in the time to first sensation 2. Changes in other upper GI symptoms 3. Change in esophageal PGE2 levels | — |
Countries
Japan
Contacts
Public ContactTakashi Kondo
Hyogo College of Medicine Department of Internal Medicine Division of Gastroenterology
Outcome results
None listed