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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1114-2148 | Registry Identifier | WHO |
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The purpose of this study was to compare the pharmacodynamics of intravenous (IV) lansoprazole to oral lansoprazole capsules, once daily (QD), in participants with erosive esophagitis.
Phase 2, open label, multi-center, 2-period study to compare the pharmacodynamics of IV lansoprazole 30 mg to oral lansoprazole 30 mg in subjects with erosive esophagitis (grade >or= 2)diagnosed by endoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lansoprazole IV 30 mg QD | Experimental |
| |
| Lansoprazole Capsule 30 mg QD | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lansoprazole | Drug | Lansoprazole 30 mg, intravenous injection, once daily for up to 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximal Acid Output obtained 22 hours after the last dose of IV lansoprazole compared to the Maximal Acid Output obtained 22 hours after the last dose of oral lansoprazole following pentagastrin stimulation in both instances. | Day 7 vs Day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| Basal Acid Output obtained 21 hours after the last dose of IV lansoprazole compared with that obtained 21 hours after the last dose of oral lansoprazole. | Day 7 vs Day 15 | |
| Maximum Acid Output and Basal Acid Output measurements obtained 21 hours and 22 hours, respectively, after the first dose of IV lansoprazole versus those obtained after the last dose of oral lansoprazole. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda | Study Director |
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| ID | Term |
|---|---|
| D004941 | Esophagitis |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
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| ID | Term |
|---|---|
| D064747 | Lansoprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Lansoprazole | Drug | Lansoprazole 30 mg, capsules, orally, once daily for up to 7 days. |
|
|
| Day 7 vs Day 8 |
| Maximum Acid Output and Basal Acid Output results obtained after the first versus last dose of IV lansoprazole. | Day 8 vs Day 15 |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |