Status:
COMPLETED
A Multicenter, Double Blinded, Randomized, Parallel Assignment Study to Demonstrate the Efficacy of DA9601
Lead Sponsor:
Dong-A ST Co., Ltd.
Conditions:
NSAID-associated Gastroduodenal Injury
Eligibility:
All Genders
20-65 years
Phase:
PHASE4
Brief Summary
This is a phase IV clinical study to evaluate the preventive effectiveness of NSAID-Associated Gastroduodenal Injury. The study is consisted of multi-center, doubleblind, active-controlled, stratified...
Detailed Description
After filling an Informed consent form, subjects are joined the clinical trials. First of all, Screening test including the endoscopy test is performed. Subjects, which fit the inclusion/Exclusion cr...
Eligibility Criteria
Inclusion
- Need to take NSAID pills for longer than four weeks
- should be normal diagnosed by the endoscopy test
Exclusion
- The patients have gastric ulcer or duodenal ulcer within 30 days
- The patients have a gastro-intestinal surgery within a year
- The patients are taking the following drugs within seven days: H2 receptor antagonist, PPI, sucralfate, misoprostol, Stillen etc)
Key Trial Info
Start Date :
September 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
520 Patients enrolled
Trial Details
Trial ID
NCT01912066
Start Date
September 1 2012
End Date
March 1 2014
Last Update
September 30 2014
Active Locations (1)
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1
Inje University Busan Paik Hospital
Busan, South Korea, 614735