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Clinical Trial to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

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ClinicalTrials.gov Identifier: NCT03928470
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
Chong Kun Dang Pharmaceutical

Brief Summary:
To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg

Condition or disease Intervention/treatment Phase
Non-erosive Reflux Disease(NERD) Drug: EsoDuo Tab. 20/800mg Phase 4

Detailed Description:
A multicenter, randomized, double-blind, active-controlled phase 4 study to evaluate the efficacy and safety of EsoDuo Tab. 20/800mg in patients with non-erosive reflux disease(NERD)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 378 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Active-controlled Phase 4 Study to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg in Patients With Non-erosive Reflux Disease(NERD)
Actual Study Start Date : January 29, 2019
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: EsoDuo Tab. 20/800mg
EsoDuo Tab. 20/800mg
Drug: EsoDuo Tab. 20/800mg
Nexium Tab. 20mg

Active Comparator: Nexium Tab. 20mg
Nexium Tab. 20mg
Drug: EsoDuo Tab. 20/800mg
Nexium Tab. 20mg




Primary Outcome Measures :
  1. Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks. [ Time Frame: 4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.


Secondary Outcome Measures :
  1. Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks. [ Time Frame: 2 weeks after drug administrations ]
    Compare Experimental group with Active Comparator.

  2. Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks. [ Time Frame: 2/4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.

  3. The percentage of Heartburn(HB) / Acid regurgitation only 1 day or less free days, 2 / 4 weeks. [ Time Frame: 2/4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.

  4. The percentage of free days without Heartburn(HB) / Acid regurgitation, 2 / 4 weeks. [ Time Frame: 2/4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.

  5. The time to the first 24/48-h, 7-d of Heartburn(HB) / Acid regurgitation free interval. [ Time Frame: 2/4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.

  6. Change from baseline in the Heartburn(HB) / Acid regurgitation Symptom score, 2 / 4 weeks. [ Time Frame: 2/4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.

  7. Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks. [ Time Frame: 4 weeks after drug administrations. ]
    Compare Experimental group with Active Comparator.

  8. Time to first resolution of Heartburn(HB), Day 1 [ Time Frame: 1 day after drug administrations. ]
    Compare Experimental group with Active Comparator.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or Female aged ≥ 19 years
  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:

  1. Surgery history on stomach or esophagus
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928470


Contacts
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Contact: Oh Young Lee, M.D., Ph.D. 82+2-2290-8343 leeoy@hanyand.ac.kr

Locations
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Korea, Republic of
Dong-A University Hospital Recruiting
Busan, Korea, Republic of
Contact: Jin Suk Jang, M.D., Ph.D.    82+51-240-2609    jsjang@dau.ac.kr   
Kosin University Gospel Hospital Recruiting
Busan, Korea, Republic of
Contact: Mu in Park, M.D., Ph.D.    82+51-990-6719    mipark@ns.kosinmed.or.kr   
Soonchunhyang University Cheonan Hospital Recruiting
Cheonan, Korea, Republic of
Contact: il Gwon Jeong, M.D., Ph.D.    82+41-570-3741    euschung@schmc.ac.kr   
Chungbuk National University Hospital Recruiting
Cheongju, Korea, Republic of
Contact: Hyung Woo Kim, M.D., Ph.D.    82+43-269-6037    broad_earth@naver.com   
Hallym University Chuncheon Seonsim Hospital Recruiting
Chuncheon, Korea, Republic of
Contact: Gwang Ho Baik, M.D., Ph.D.    82+33-240-5810    baikgh2@daum.net   
Daegu Catholic Hospital Recruiting
Daegu, Korea, Republic of
Contact: Eun young Kim, M.D., Ph.D.    82+53-650-4092    kimey@cu.ac.kr   
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of
Contact: KyungSik Park, M.D., Ph.D.    82+53-250-7088    seenae99@dsmc.or.kr   
Yeungnam University Medicar Center Recruiting
Daegu, Korea, Republic of
Contact: Tae Nyeun Kim, M.D., Ph.D.    82+53-620-3897    tnkim@yu.ac.kr   
Chungnam National University Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Jae Kyu Sung, M.D., Ph.D.    82+42-280-7186    jksung69@gmail.com   
Myongji Hospital Recruiting
Goyang, Korea, Republic of
Contact: Jung Ho Kim, M.D., Ph.D.    +82+10-8920-0489    med21k@hanmail.net   
Chonnam National University Hospital Recruiting
Gwangju, Korea, Republic of
Contact: Jongsun Rew, M.D., Ph.D.    82+63-250-1684    soo@jbnu.ac.kr   
Ajou University Hospital Recruiting
Gyeonggi-do, Korea, Republic of
Contact: Kwang Jae Lee, M.D., Ph.D.    82+31-219-7049    kjl@ajou.ac.kr   
Hanyang University Guri Hospital Recruiting
Gyeonggi-do, Korea, Republic of
Contact: Yongcheol Jeon, M.D., Ph.D.    82+31-560-2227    ycjeon@hanyang.ac.kr   
Inje University ilsan Paik Hospital Recruiting
Gyeonggi-do, Korea, Republic of
Contact: Nam hoon Kim, M.D., Ph.D.    82+31-910-7200    n-hkim@paik.ac.kr   
Soonchunhyang University Bucheon Hospital Recruiting
Gyeonggi-do, Korea, Republic of
Contact: Su jin Hong, M.D., Ph.D.    82+32-621-0950    sjhong@schmc.ac.kr   
Wonkwang University Hospital Recruiting
Iksan, Korea, Republic of
Contact: SeokChae Choi, M.D., Ph.D.    82+63-859-2563    medcsc@wonkwang.ac.kr   
Dongguk University IIsan Hospital Recruiting
Ilsan, Korea, Republic of
Contact: Jun gyu Lee, M.D., Ph.D.    82+31-961-7740    jeromee1971@daum.net   
Gachon Gil Hospital Recruiting
Incheon, Korea, Republic of
Contact: jung ho kim, M.D., Ph.D.    82+32-460-3418    junghokimm@gilhospital.com   
Jeju National University Hospital Recruiting
Jeju, Korea, Republic of
Contact: EunKwang Choi, M.D., Ph.D.    82+64-717-1130    blessed-light@daum.net   
Chonbuk National University Hospital Recruiting
Jeonju, Korea, Republic of
Contact: Suk Taek Lee, M.D., Ph.D.    82+63-250-1684    soo@jbnu.ac.kr   
Inje University Busan Paik Hospital Recruiting
Pusan, Korea, Republic of
Contact: Samryong Ji, M.D., Ph.D.    82+531-890-8725    srjee@inje.ac.kr   
Inje University Haeundae Paik Hospital Recruiting
Pusan, Korea, Republic of
Contact: Tae-oh Kim, M.D., Ph.D.    82+51-797-0200    Kto0440@paik.ac.kr   
Pusan National University Hospital Recruiting
Pusan, Korea, Republic of
Contact: Gwang ha Kim, M.D., Ph.D.    82+51-240-6012    doc0224@pusan.ac.kr   
Yangsan Pusan National University Hospital Recruiting
Pusan, Korea, Republic of
Contact: Dae Hwan Kang, M.D., Ph.D.    81+55-360-1412    sulsulpul@naver.com   
Asan Medical Center, Seoul Recruiting
Seoul, Korea, Republic of
Contact: Hun Yong Jeong, M.D., Ph.D.    82+2-3010-5645    hwoonymd@gmail.com   
Catholic University Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Choi Myung Kyu, M.D., Ph.D.    82+2-2258-2085    choim@catholic.ac.kr   
Chung Ang University Hospital Enrolling by invitation
Seoul, Korea, Republic of
Gangnam Severance Recruiting
Seoul, Korea, Republic of
Contact: Ji Hyun Kim, M.D., Ph.D.    82+2-2019-4880    otilia94@yuhs.ac   
Hanyang University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Oh Young Lee, M.D., Ph.D.    82+2-2290-8343    leeoy@hanyand.ac.kr   
Konkuk University Hospital Recruiting
Seoul, Korea, Republic of
Contact: In Gyeong Seong, M.D., Ph.D.    82+2-2030-7504    iksung@kuh.ac.kr   
Korea University Anam Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jeon Hun Jae, M.D., Ph.D.    82+2-920-6561    drchunhj@gmail.com   
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jong Jae Park, M.D., Ph.D.    82+2-2626-3003    gi7pjj@yahoo.co.kr   
Kyunghee Universtiy Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jae Young Jang, M.D., Ph.D.    82+2-958-8260    jyjang@khu.ac.kr   
Samsung Seoul Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jae Joon Kim, M.D., Ph.D.    82+2-3410-3409    jaej.kim@samsung.com   
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Hyunsoo Jeong, M.D., Ph.D.    82+2-2071-4844    hschungmd@gmail.com   
Severange Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yong Chan Lee, M.D., Ph.D.    82+2-2228-0521    leeyc@yuhs.ac   
Soonchunhyang University Seoul Hospital Recruiting
Seoul, Korea, Republic of
Contact: Jun sung Lee, M.D., Ph.D.    82+2-709-9202    joonlee@schmc.ac.kr   
Wonju Severance Christian Hospital Recruiting
Wŏnju, Korea, Republic of
Contact: Hyunsoo Kim, M.D., Ph.D.    82+33-741-1227    hyskim@yonsei.ac.kr   
Sponsors and Collaborators
Chong Kun Dang Pharmaceutical
Investigators
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Principal Investigator: Oh Young Lee, M.D., Ph.D. Hanyang University

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Responsible Party: Chong Kun Dang Pharmaceutical
ClinicalTrials.gov Identifier: NCT03928470     History of Changes
Other Study ID Numbers: 273GERD18019
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases