Clinical Trial to Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg
- Conditions
- Non-erosive Reflux Disease(NERD)
- Interventions
- Drug: EsoDuo Tab. 20/800mg
- Registration Number
- NCT03928470
- Lead Sponsor
- Chong Kun Dang Pharmaceutical
- Brief Summary
To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 379
- Male or Female aged ≥ 19 years
- Episode of heartburn for 3 months or more during prior to randomization visit.
- Episode of heartburn for 2 days or more during the last 7 days prior to randomization visit.
- Grade N, M by EGD test.
- Surgery history on stomach or esophagus
- Active medical history of stomach, esophagus area
- Other system disorder which can disturb this trial
- Patients taking the contraindication of concomitant medications
- Clinically significant Abnormal Lab test
- Pregnant woman, Breastfeeding woman.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EsoDuo Tab. 20/800mg EsoDuo Tab. 20/800mg EsoDuo Tab. 20/800mg Nexium Tab. 20mg EsoDuo Tab. 20/800mg Nexium Tab. 20mg
- Primary Outcome Measures
Name Time Method Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks. 4 weeks after drug administrations. Compare Experimental group with Active Comparator.
- Secondary Outcome Measures
Name Time Method Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks. 2 weeks after drug administrations Compare Experimental group with Active Comparator.
Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks. 2/4 weeks after drug administrations. Compare Experimental group with Active Comparator.
The percentage of Heartburn(HB) / Acid regurgitation only 1 day or less free days, 2 / 4 weeks. 2/4 weeks after drug administrations. Compare Experimental group with Active Comparator.
The percentage of free days without Heartburn(HB) / Acid regurgitation, 2 / 4 weeks. 2/4 weeks after drug administrations. Compare Experimental group with Active Comparator.
The time to the first 24/48-h, 7-d of Heartburn(HB) / Acid regurgitation free interval. 2/4 weeks after drug administrations. Compare Experimental group with Active Comparator.
Change from baseline in the Heartburn(HB) / Acid regurgitation Symptom score, 2 / 4 weeks. 2/4 weeks after drug administrations. Compare Experimental group with Active Comparator.
Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks. 4 weeks after drug administrations. Compare Experimental group with Active Comparator.
Time to first resolution of Heartburn(HB), Day 1 1 day after drug administrations. Compare Experimental group with Active Comparator.
Trial Locations
- Locations (38)
Dong-A University Hospital
🇰🇷Busan, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Hallym University Chuncheon Seonsim Hospital
🇰🇷Chuncheon, Korea, Republic of
Ajou University Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongju, Korea, Republic of
Chungnam National University Hospital
🇰🇷Daejeon, Korea, Republic of
Soonchunhyang University Cheonan Hospital
🇰🇷Cheonan, Korea, Republic of
Gachon Gil Hospital
🇰🇷Incheon, Korea, Republic of
Daegu Catholic Hospital
🇰🇷Daegu, Korea, Republic of
Myongji Hospital
🇰🇷Goyang, Korea, Republic of
Hanyang University Guri Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Inje University Busan Paik Hospital
🇰🇷Pusan, Korea, Republic of
Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Yangsan Pusan National University Hospital
🇰🇷Pusan, Korea, Republic of
Gangnam Severance
🇰🇷Seoul, Korea, Republic of
Konkuk University Hospital
🇰🇷Seoul, Korea, Republic of
Yeungnam University Medicar Center
🇰🇷Daegu, Korea, Republic of
Keimyung University Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Soonchunhyang University Bucheon Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Inje University ilsan Paik Hospital
🇰🇷Gyeonggi-do, Korea, Republic of
Jeju National University Hospital
🇰🇷Jeju, Korea, Republic of
Chonbuk National University Hospital
🇰🇷Jeonju, Korea, Republic of
Dongguk University IIsan Hospital
🇰🇷Ilsan, Korea, Republic of
Wonkwang University Hospital
🇰🇷Iksan, Korea, Republic of
Asan Medical Center, Seoul
🇰🇷Seoul, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Inje University Haeundae Paik Hospital
🇰🇷Pusan, Korea, Republic of
Catholic University Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Chung Ang University Hospital
🇰🇷Seoul, Korea, Republic of
Hanyang University Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Wonju Severance Christian Hospital
🇰🇷Wŏnju, Korea, Republic of
Korea University Guro Hospital
🇰🇷Seoul, Korea, Republic of
Kyunghee Universtiy Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of