Gastroesophageal Reflux Disease
Conditions
Brief summary
The gastric acid pocket is believed to be the reservoir from which acid reflux events originate. The risk for acidic reflux is mainly determined by the position of the gastric acid pocket. Little is known about how changes in position and size of the acid pocket contribute to the therapeutic effect of proton pump inhibitors(PPI) plus mosapride in patients with gastroesophageal reflux disease. Investigators will conduct a prospective randomized, single blind and placebo-controlled clinical trial to evaluate the hypothesis that mosapride affecting gastric motility might reduce gastro-esophageal reflux by changing the acid pocket position and size.
Interventions
DRUGAdministration of study drug (esomeprazole, mosapride)
Esomeprazole(Hanxium®) 40 mg once daily and mosapride (Gasmotin®) 5 mg t.i.d for 4 weeks.
DRUGAdministration of study drug (esomeprazole, placebo tablet)
Esomeprazole(Hanxium®) 40 mg once daily and placebo tablets that are identical to mosapride tablets t.i.d (3 times a day) for 4 weeks.
PROCEDUREupper endoscopy, scintigraphy
After medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy.
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with diagnosed GERD(gastro-esophageal reflux disease), defined by the presence of oesophagitis obtained during a previous upper endoscopy or typical GERD symptoms(heartburn, acid reflux).
Exclusion criteria
* who had organic gastrointestinal disease including inflammatory bowel disease, cancer and ulcer * who took drugs which could affect evaluation of the treatment; other PPIs, H2RAs(H2 receptor antagonists), prokinetics,mucosal protective agents, antacids, cholinergic and anticholinergic agents, and antidepressants for at least 4 weeks prior to study start * who had severe systemic diseases including hepatic and nephrotic disease * who had previous gastrectomy history * who was in state of pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Size(cm2) of the acid pocket between PPI+placebo group and PPI+mosapride group | After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride) | The size of the acid pocket will be determined by drawing an area of interest over the acid pocket in the proximal stomach in images(scintigraphy) taken at 10-minute intervals. |
| Location(cm) of the acid pocket between PPI+placebo group and PPI+mosapride group | After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride) | Measurements of the distances between the acid pocket and the diaphragm will be make through a straight line in a planar posterior view of the stomach in images(scintigraphy) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement of reflux symptom | After 4weeks of drug treatment(PPI+placebo vs. PPI + mosapride) | Using RDQ(Reflux Disease Questionnaire) |
Contacts
Primary ContactHyojin Park, MD, PhD
Outcome results
None listed