Status:
UNKNOWN
S-pantoprazole 10mg Phase III Clinical Study
Lead Sponsor:
Ahn-Gook Pharmaceuticals Co.,Ltd
Conditions:
Non Erosive Reflux Disease
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
Brief Summary
This clinical study hypothesized that S-pantoprazole 10mg would be effective to treat Non erosive Reflux Disease than placebo.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT02274961
Start Date
October 1 2014
Last Update
October 27 2014
Active Locations (10)
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1
Yeungnam University Medical Center
Daegu, Daegu, South Korea
2
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, South Korea
3
Bundang CHA Medical Center
Sung-Nam, Gyeonggi-do, South Korea
4
Seoul National University Bundang Hospital
Sung-Nam, Gyeonggi-do, South Korea