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A randomized, double-blind, double-dummy, active comparator, multi-centers, non-inferiority design clinical trial to assess the efficacy and safety of YYD601 in ERD patients (phase 3).
This phase 3 clinical trial is designed as randomized, active-comparator, double-dummy, multi-center for ERD patients, who take YYD601 40mg or Nexium 40mg for 8 weeks. Each part is assessed by 'LA grade' measured through the endoscopy, target goal is to confirm the non-inferiority of YYD601 40mg to Nexium 40mg.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YYD601 40mg | Experimental | Esomeprazole magnesium Dihydrate. |
|
| Nexium 40mg | Active Comparator | Esomeprazole magnesium trihydrate, a substituted benzimidazole. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| YYD601 40mg | Drug | Patients should take druges 30 minutes before breakfast. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| LA grade 0(zero) | Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) within week 8. Calculation of the sample size was based on a margin of non-inferiority by Normal approximation. | within 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| LA grade 0(zero) | Percentage of patients(%) who's erosive esophagitis has been recovered to LA grade 0(zero) by Normal approximation and Fisher's exact test. | at 4 weeks |
| Frequency variation of the Heartburn and acid regurgitation by RDQ(questionnaire). |
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Inclusion Criteria:
A man or woman over 20 years old less than 70 years old.
A man or woman who has experienced symptom (heartburn and acid regurgitation) within 7 days before Visit 1, meet below 1) or 2) criteria, who has been made diagnosis as Erosive esophagitis(LA grade A~D) measured through the endoscopy which is carried out within (-2W±D2)
* Symptom (heartburn and acid regurgitation) is confirmed by RDQ.
A man or woman who has a full understanding of this clinical trial through the detailed explanation, agree in writing to participate in this trial.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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| Nexium 40mg |
| Drug |
Patients should take druges 30 minutes before breakfast. |
|
| Placebos | Drug | The placebo YYD601 is made from microcrystalline cellulose covered with hard shell. The placebo Nexium is made from microcrystalline cellulose, Crospovidone, Magnesiumstearat and other ingredients. |
|
Change in frequency of the symptom(heartburn and acid regurgitation) by Shapiro-Wilk test and Wilcoxon's rank sum test. |
| at week 4 and 8 from baseline |
| Frequency variation of the Heartburn in daytime by patients diary | Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test. | at 4 week and 8 week from baseline |
| Frequency variation of the Heartburn in nighttime by patients diary | Percentage of patients(%) who have the symptom(heartburn and acid regurgitation) by Chi-square test and Fisher's exact test. | at 4 week and 8 week from baseline |
| Days percentage(%) of no symptoms about the Heartburn and acid regurgitation | Patients who have experienced the heartburn and acid regurgitation in nighttime by patients diary. | at week 4 and 8 from baseline |
| 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 |