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Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to investigate the safety, tolerability and efficacy of YH1885L in patients with non-erosive reflux disease(NERD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YH1885L 33.3 mg | Experimental | TID, Subject takes it for 4 week. |
|
| YH1885L 50mg | Experimental | BID, Subject takes it for 4 week. |
|
| YH1885L 66.6 mg | Experimental | TID, Subject takes it for 4 week. |
|
| YH1885L 100mg | Experimental | BID, Subject takes it for 4 week. |
|
| Esomeprazole 20mg | Active Comparator | QD, Subject takes it for 4 week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YH1885L(Revaprazan) | Drug |
| ||
| Measure | Description | Time Frame |
|---|---|---|
| the rate of subject who had 'complete recovery' of symptom after 4 week administration | 'complete recovery' means subjects never experience heartburn or acid regurgitation during last 1 week. | 4 week |
| Measure | Description | Time Frame |
|---|---|---|
| the rate of subject who had 'appropriate recovery' of symptom after 4 week administration | 'Appropriate recovery' means subjects experience heartburn or acid regurgitation only 1 or less during last 1 week. | 4 week |
| the rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of H.pylori(+),(-) subjects about primay and seconday outcome | 4 week |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic yeouido sungmo hospital | Seoul | Seoul | South Korea | |||
| DongA university hospital |
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| Esomeprazole 20mg |
| Drug |
|
|
| placebo | Drug |
|
| 3 week |
| the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion | 3 week |
| the number of night symptom-free day after IP administration | Symptoms means "Heartburn or Acid regurgitation" | 1 week, 2 week, 3 week, 4 week |
| the rate of subjects who have reduced average symptom score(more than 1) comparing to baseline score | 1 week, 2 week, 3 week, 4 week |
| Evalution of Clinical Global Impression of Change | 4 week |
| Evaluation of Patient Global Impression of Change | 4 week |
| the change of SF-36 Survey score between baseline and completion visit | 4 week |
| the change of ESS survey score among baseline, 2 week and 4 week | ESS stands for Epworth sleepiness scale. | 2, 4 week |
| Safety | AE, Physical exam, 12-lead ECG, Vital signs, laboratory test | 4 week |
| Busan |
| South Korea |
| Kyungbook University hospital | Daegu | South Korea |
| Chungnam university hospital | Daejeon | South Korea |
| Catholic Incheon hospital | Incheon | South Korea |
| Jeonbuk University hospital | Jeonju | South Korea |
| Asan hospital | Seoul | South Korea |
| Konkuk unversity hospital | Seoul | South Korea |
| Kyunghee university hospital | Seoul | South Korea |
| Seoul university hospital | Seoul | South Korea |
| ID | Term |
|---|---|
| D000096663 | Non-Erosive Reflux Disease |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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