To Evaluate the Efficacy and Safety of DW1903 in Acute and Chronic Gastritis Patient
NCT ID: NCT05163756
Last Updated: 2021-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
332 participants
INTERVENTIONAL
2020-11-25
2021-05-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DW1903(Test)
once a day, q.d. PO / DW1903 + Placebo of DW1903-R1
DW1903
q.d. PO, DW1903 + Placebo of DW1903-R1
DW1903-R1(Reference)
once a day, q.d. PO / Placebo of DW1903 + DW1903-R1
DW1903-R1
q.d. PO, Placebo of DW1903 + DW1903-R1
Interventions
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DW1903
q.d. PO, DW1903 + Placebo of DW1903-R1
DW1903-R1
q.d. PO, Placebo of DW1903 + DW1903-R1
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
* 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.
19 Years
75 Years
ALL
No
Sponsors
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Daewon Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Korea University Ansan Hospital
Seoul, , South Korea
Countries
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References
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Kim JH, Jung HY, Yoo IK, Park SY, Kim JG, Sung JK, Jang JS, Cheon GJ, Kim KO, Kim TO, Lee ST, Cho KB, Chun HJ, Park JJ, Park MI, Jang JY, Jeon SW, Cho JW, Kang DH, Kim GH, Kim JJ, Kim SG, Kim N, Lee YC, Hong SJ, Kim HS, Lee S, Lee SW. Evaluation of the Efficacy and Safety of DW1903 in Patients with Gastritis: A Randomized, Double-Blind, Noninferiority, Multicenter, Phase 3 study. Gut Liver. 2024 Jan 15;18(1):70-76. doi: 10.5009/gnl220446. Epub 2023 Jun 13.
Other Identifiers
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DW1903-301
Identifier Type: -
Identifier Source: org_study_id