Clinical Trial to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg
NCT ID: NCT03928470
Last Updated: 2019-12-24
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
PHASE4
379 participants
INTERVENTIONAL
2019-01-29
2019-12-20
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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EsoDuo Tab. 20/800mg
EsoDuo Tab. 20/800mg
EsoDuo Tab. 20/800mg
Nexium Tab. 20mg
Nexium Tab. 20mg
Nexium Tab. 20mg
EsoDuo Tab. 20/800mg
Nexium Tab. 20mg
Interventions
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EsoDuo Tab. 20/800mg
Nexium Tab. 20mg
Eligibility Criteria
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Inclusion Criteria
2. Episode of heartburn for 3 months or more during prior to randomization visit.
3. Episode of heartburn for 2 days or more during the last 7 days prior to randomization visit.
4. Grade N, M by EGD test.
Exclusion Criteria
2. Active medical history of stomach, esophagus area
3. Other system disorder which can disturb this trial
4. Patients taking the contraindication of concomitant medications
5. Clinically significant Abnormal Lab test
6. Pregnant woman, Breastfeeding woman.
19 Years
ALL
No
Sponsors
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Chong Kun Dang Pharmaceutical
INDUSTRY
Responsible Party
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Principal Investigators
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Oh Young Lee, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Locations
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Dong-A University Hospital
Busan, , South Korea
Kosin University Gospel Hospital
Busan, , South Korea
Soonchunhyang University Cheonan Hospital
Cheonan, , South Korea
Chungbuk National University Hospital
Cheongju-si, , South Korea
Hallym University Chuncheon Seonsim Hospital
Chuncheon, , South Korea
Daegu Catholic Hospital
Daegu, , South Korea
Keimyung University Dongsan Medical Center
Daegu, , South Korea
Yeungnam University Medicar Center
Daegu, , South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Myongji Hospital
Goyang, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Ajou University Hospital
Gyeonggi-do, , South Korea
Hanyang University Guri Hospital
Gyeonggi-do, , South Korea
Inje University ilsan Paik Hospital
Gyeonggi-do, , South Korea
Soonchunhyang University Bucheon Hospital
Gyeonggi-do, , South Korea
Wonkwang University Hospital
Iksan, , South Korea
Dongguk University IIsan Hospital
Ilsan, , South Korea
Gachon Gil Hospital
Incheon, , South Korea
Jeju National University Hospital
Jeju City, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Inje University Busan Paik Hospital
Pusan, , South Korea
Inje University Haeundae Paik Hospital
Pusan, , South Korea
Pusan National University Hospital
Pusan, , South Korea
Yangsan Pusan National University Hospital
Pusan, , South Korea
Asan Medical Center, Seoul
Seoul, , South Korea
Catholic University Seoul St. Mary's Hospital
Seoul, , South Korea
Chung Ang University Hospital
Seoul, , South Korea
Gangnam Severance
Seoul, , South Korea
Hanyang University Hospital
Seoul, , South Korea
Konkuk University Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Korea University Guro Hospital
Seoul, , South Korea
Kyunghee Universtiy Hospital
Seoul, , South Korea
Samsung Seoul Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Soonchunhyang University Seoul Hospital
Seoul, , South Korea
Wonju Severance Christian Hospital
Wŏnju, , South Korea
Countries
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References
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Park SH, Lee KN, Lee OY, Choi MG, Kim JH, Sung IK, Jang JY, Park KS, Chun HJ, Kim EY, Lee JK, Jang JS, Kim GH, Hong SJ, Lee YC, Choi SC, Kim HS, Kim TO, Baik GH, Jeon YC. A Randomized, Double-Blind, Active-Control, Noninferiority, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of Esomeprazole/Sodium Bicarbonate 20/800 mg in Patients with Nonerosive Gastroesophageal Reflux Disease. Gut Liver. 2023 Mar 15;17(2):226-233. doi: 10.5009/gnl220023. Epub 2022 Jun 22.
Other Identifiers
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273GERD18019
Identifier Type: -
Identifier Source: org_study_id