Non Erosive Reflux Disease
Conditions
Brief summary
This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non erosive Reflux Disease than placebo.
Interventions
DRUGS-pantoprazole 10mg
DRUGPlacebo
Sponsors
Ahn-Gook Pharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults between the ages of 19 and 75 inclusive * Patient with a history of heartburn or acid regurgitation for at least 3 months. * Those with episodes of heartburn for 2 days or more during the last 7 days prior to baseline * Patients negative for erosive esophagitis confirmed by esophagogastroduodenoscopy(EGD) performed within 7 days of screening * Capable of providing written informed consent, willing and able to a comply with all procedures of the study
Exclusion criteria
* History of endoscopic erosive esophagitis(EE) at screening EGD. * Historical evidence of the following disease/conditions : symptom of Irritable bowel syndrome * More tha 3cm endoscopic Barrett's esophagus or significant dysplastic changes in the esophagus * Proton Pump Inhibitor(PPI) within 4 weeks prior to the baseline visit * H2-receptor antagonist, sucralfate, prokinetics, Non Steroidal Antiinflammatory Drugs(NSAIDs) (except low dose aspirin) during the 2 weeks prior to the screening * Historical evidence of the following disease/conditions during 3 months: Zollinger-Ellison syndrome, the primary esophageal motility disorders achalasia, esophageal stricture, pancreatitis, gastric ulcer, evidence of upper G.I. malignancy, pancreatitis, malabsorption, severe cardiovascular or pulmonary disease, severe liver disease, severe renal disease, cerebral vascular disease, * Known hypersensitivity to any component of drug * pregnancy or lactation (F only)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the efficacy , as defined by complete resolution of heartburn (HB) per Questionnaire, of 4 weeks of treatment of S-pantoprazole 10mg qd compared to Placebo in subjects with symptomatic gastro-esophageal reflux disease | 4 weeks |
Countries
South Korea
Contacts
Primary ContactJINHYUNG KIM, Senior Researcher
Backup ContactChulhun Sung, Senior Researcher
Outcome results
None listed