Status:
COMPLETED
To Evaluate the Efficacy and Safety of DW-1401 in Acute and Chronic Gastritis Patients
Lead Sponsor:
Daewon Pharmaceutical Co., Ltd.
Conditions:
Gastritis Acute
Gastritis Chronic
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
Brief Summary
Evaluate the Efficacy and Safety of DW1401 versus Stillen tab. in Patients with Acute or Chronic Gastritis
Eligibility Criteria
Inclusion
- Patients who were diagnosed with acute or chronic gastritis in a gastroscopy performed within 7 days prior to administration of this trial.
- At least one or more erosions have been identified on gastroscopy.
- Patients who decided to voluntarily participate in this trial and agreed in writing.
Exclusion
- Patients who can not undergo gastroscopy
- Peptic ulcer (except scarring) and reflux esophagitis
- Patients who have had gastric acid suppression surgery or stomach/esophagus surgery (except for simple perforation surgery and appendectomy)
- Patients with a history of gastrointestinal malignancies
- Zollinger-Ellison syndrome patients
- Patient with spontaneous coagulation disorder
- Patients with an allergic or hypersensitive response to a study drug
- Patients with a potential pregnancy.
- Patients who had clinically significant abnormalities in the screening test. (ALT, AST, BUN, Serum creatinine is more than twice the upper limit)
- Pregnant and lactating women
- Those currently taking other study drugs
- patients who were judged to be ineligible for the trial by the principle investigator and the person in charge.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
462 Patients enrolled
Trial Details
Trial ID
NCT03443804
Start Date
July 1 2014
End Date
November 1 2014
Last Update
February 28 2018
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