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The purpose of this study is to demonstrate the superiority of efficacy of CJ-12420, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4
This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg or 100 mg or placebo).
All subjects will be asked to take two tablets at the same time each day throughout the study, and also all subjects will be asked to record daily symptom in a subject diary on a daily basis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CJ-12420 50mg | Experimental | CJ-12420 50 mg, tablet, once daily, oral administration for up to 4 weeks |
|
| CJ-12420 100mg | Experimental | CJ-12420 100 mg, tablet, once daily, oral administration for up to 4 weeks |
|
| Placebo | Placebo Comparator | Placebo, tablet, once daily, oral administration for up to 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CJ-12420 50mg | Drug | CJ-12420 50mg, tablet, once daily, oral administration for up to 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with complete resolution of main symptoms (heartburn and regurgitation) at 4-week, defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ) | 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of main symptoms(heartburn and regurgitation) at 2-week(for 7 consecutive days) | 2 week | |
| RDQ score change | 4 week | |
| Percentage of symptom free days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yeouido St.Mary's Hospital | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34227708 | Derived | Kim SH, Cho KB, Chun HJ, Lee SW, Kwon JG, Lee DH, Kim SG, Jung HY, Kim JW, Lee JS, Park H, Choi SC, Jee SR, Kim HS, Ko KH, Park SJ, Lee YC, Park SH, Kim AR, Kim EJ, Park HW, Kim BT, Song GS. Randomised clinical trial: comparison of tegoprazan and placebo in non-erosive reflux disease. Aliment Pharmacol Ther. 2021 Aug;54(4):402-411. doi: 10.1111/apt.16477. Epub 2021 Jul 6. |
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| ID | Term |
|---|---|
| D000096663 | Non-Erosive Reflux Disease |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
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| CJ-12420 100mg | Drug | CJ-12420 100mg, tablet, once daily, oral administration for up to 4 weeks |
|
|
| Placebo | Drug | Placebo, tablet, once daily, oral administration for up to 4 weeks |
|
Symptom will be collected by patient diary. |
| 4 week |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |