Non-erosive Reflux Disease(NERD) Clinical Trial
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)
| Verified date | December 2019 |
| Source | Chong Kun Dang Pharmaceutical |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To Evaluate the Efficacy and Safety of EsoDuo Tab. 20/800mg
| Status | Completed |
| Enrollment | 379 |
| Est. completion date | December 20, 2019 |
| Est. primary completion date | December 20, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Dong-A University Hospital | Busan | |
| Korea, Republic of | Kosin University Gospel Hospital | Busan | |
| Korea, Republic of | Soonchunhyang University Cheonan Hospital | Cheonan | |
| Korea, Republic of | Chungbuk National University Hospital | Cheongju | |
| Korea, Republic of | Hallym University Chuncheon Seonsim Hospital | Chuncheon | |
| Korea, Republic of | Daegu Catholic Hospital | Daegu | |
| Korea, Republic of | Keimyung University Dongsan Medical Center | Daegu | |
| Korea, Republic of | Yeungnam University Medicar Center | Daegu | |
| Korea, Republic of | Chungnam National University Hospital | Daejeon | |
| Korea, Republic of | Myongji Hospital | Goyang | |
| Korea, Republic of | Chonnam National University Hospital | Gwangju | |
| Korea, Republic of | Ajou University Hospital | Gyeonggi-do | |
| Korea, Republic of | Hanyang University Guri Hospital | Gyeonggi-do | |
| Korea, Republic of | Inje University ilsan Paik Hospital | Gyeonggi-do | |
| Korea, Republic of | Soonchunhyang University Bucheon Hospital | Gyeonggi-do | |
| Korea, Republic of | Wonkwang University Hospital | Iksan | |
| Korea, Republic of | Dongguk University IIsan Hospital | Ilsan | |
| Korea, Republic of | Gachon Gil Hospital | Incheon | |
| Korea, Republic of | Jeju National University Hospital | Jeju | |
| Korea, Republic of | Chonbuk National University Hospital | Jeonju | |
| Korea, Republic of | Inje University Busan Paik Hospital | Pusan | |
| Korea, Republic of | Inje University Haeundae Paik Hospital | Pusan | |
| Korea, Republic of | Pusan National University Hospital | Pusan | |
| Korea, Republic of | Yangsan Pusan National University Hospital | Pusan | |
| Korea, Republic of | Asan Medical Center, Seoul | Seoul | |
| Korea, Republic of | Catholic University Seoul St. Mary's Hospital | Seoul | |
| Korea, Republic of | Chung Ang University Hospital | Seoul | |
| Korea, Republic of | Gangnam Severance | Seoul | |
| Korea, Republic of | Hanyang University Hospital | Seoul | |
| Korea, Republic of | Konkuk University Hospital | Seoul | |
| Korea, Republic of | Korea University Anam Hospital | Seoul | |
| Korea, Republic of | Korea University Guro Hospital | Seoul | |
| Korea, Republic of | Kyunghee Universtiy Hospital | Seoul | |
| Korea, Republic of | Samsung Seoul Hospital | Seoul | |
| Korea, Republic of | Seoul National University Hospital | Seoul | |
| Korea, Republic of | Severance Hospital | Seoul | |
| Korea, Republic of | Soonchunhyang University Seoul Hospital | Seoul | |
| Korea, Republic of | Wonju Severance Christian Hospital | Wonju |
| Lead Sponsor | Collaborator |
|---|---|
| Chong Kun Dang Pharmaceutical |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complete resolution of heartburn(HB), Last 7 days of treatment, 4 weeks. | Compare Experimental group with Active Comparator. | 4 weeks after drug administrations. | |
| Secondary | Complete resolution of heartburn(HB), Last 7 days of treatment, 2 weeks. | Compare Experimental group with Active Comparator. | 2 weeks after drug administrations | |
| Secondary | Complete resolution of Acid regurgitation, Last 7 days of treatment, 2 / 4 weeks. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. | |
| Secondary | The percentage of Heartburn(HB) / Acid regurgitation only 1 day or less free days, 2 / 4 weeks. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. | |
| Secondary | The percentage of free days without Heartburn(HB) / Acid regurgitation, 2 / 4 weeks. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. | |
| Secondary | The time to the first 24/48-h, 7-d of Heartburn(HB) / Acid regurgitation free interval. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. | |
| Secondary | Change from baseline in the Heartburn(HB) / Acid regurgitation Symptom score, 2 / 4 weeks. | Compare Experimental group with Active Comparator. | 2/4 weeks after drug administrations. | |
| Secondary | Heartburn(HB) / Acid regurgitation symptoms per investigator assessment, 4weeks. | Compare Experimental group with Active Comparator. | 4 weeks after drug administrations. | |
| Secondary | Time to first resolution of Heartburn(HB), Day 1 | Compare Experimental group with Active Comparator. | 1 day after drug administrations. |