Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| D9612L00046 |
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
This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Nexium |
|
| 2 | Active Comparator | Prevacid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esomeprazole | Drug | 40mg once daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the difference in healing rates of erosive esophagitis (EE) between esomeprazole 40 mg qd (E40) and lansoprazole 30 mg qd (L30) in patients with moderate or severe EE, defined as Grade C or D in the Los Angeles (LA) Classification scale. | Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4) |
| Measure | Description | Time Frame |
|---|---|---|
| 1. To compare the difference in the resolution of, and relief of, the investigator evaluated GERD symptoms of heartburn, acid regurgitation, dysphagia, and epigastric pain between E40 and L30 at week 4 of treatment in patients with moderate or severe EE. | Esophagogastroduodenoscopy (EGD) at baseline and then week 4 and week 8 (if not healed at week 4) | |
| 1. To compare the difference between E40 and L30 in the occurrence of heartburn symptoms as reported in the patient's daily diary. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paula Fernstrom | Nexium Global Product Director, AstraZeneca | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lansoprazole |
| Drug |
30mg once daily |
|
|
| Dairy card to be completed by patient daily |
| To evaluate safety and tolerability of E40 compared to that of L30 in patients with moderate or severe EE. | Adverse event collection on an ongoing basis |
| ID | Term |
|---|---|
| D006356 | Heartburn |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| D064747 | Lansoprazole |
| 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 |
Not provided
Not provided