Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and safety of Z-215 (10 mg, 20 mg, 40 mg) , compared with Rabeprazole Sodium 10mg in patients with erosive esophagitis of Grade A to D as defined by the LA classification grading system.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Z-215 10 mg/day | Experimental | Drug: Z-215 10mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo |
|
| Z-215 20 mg/day | Experimental | Drug: Z-215 20mg Drug: Z-215 Placebo Drug: Rabeprazole Sodium Placebo |
|
| Z-215 40 mg/day | Experimental | Drug: Z-215 20mg Drug: Z-215 20mg Drug: Rabeprazole Sodium Placebo |
|
| Rabeprazole Sodium 10 mg/day | Active Comparator | Drug: Z-215 Placebo Drug: Z-215 Placebo Drug: Rabeprazole Sodium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Z-215 10mg | Drug | Z-215 10mg, capsules |
| |
| Z-215 20mg |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic Healing Rate Over 8 Weeks of Erosive Esophagitis | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic Healing Rate Over 4 Weeks of Erosive Esophagitis | 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tokyo | Japan |
Not provided
| ID | Term |
|---|---|
| D004942 | Esophagitis, Peptic |
| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
Z-215 20mg, capsules |
|
| Z-215 Placebo | Drug | Z-215 placebo-matching capsules |
|
| Rabeprazole Sodium | Drug | Rabeprazole Sodium 10mg tablets |
|
| Rabeprazole Sodium Placebo | Drug | Rabeprazole Sodium Placebo placebo-matching tablets |
|
| D005759 |
| Gastroenteritis |
| D010437 | Peptic Ulcer |
| D004378 | Duodenal Diseases |
| D007410 | Intestinal Diseases |
| D013272 | Stomach Diseases |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |