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A phase 3,double-blinded, double dummy, parallel, non-inferiority, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anaprazole Sodium + Rabeprazole Placebo | Experimental | administered orally once every 30-60 minutes before breakfast for 4 weeks |
|
| Rabeprazole +Anaprazole Sodium Placebo | Active Comparator | administered orally once every 30-60 minutes before breakfast for 4 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anaprazole Sodium | Drug | administered orally once every 30-60 minutes before breakfast for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The endoscopic healing rate of duodenal ulcers at week 4, evaluated by blinded independency central reading. | The endoscopic ulcer healing rate is defined as the percentage of patients healed (complete healing and significant response) in whom the endoscopic response of duodenal ulcers at week 4 has been evaluated by blinded independency central reading. | Treatment of 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The endoscopic healing rate of duodenal ulcers at week 4, evaluated by investigator reading. | The endoscopic ulcer healing rate is defined as the percentage of patients healed (complete healing and significant response) in whom the endoscopic response of duodenal ulcers at week 4 has been evaluated by investigators. | Treatment of 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38910891 | Derived | Ni H, Shi J, Hu M, Zhou N, Yang S. Cost-effectiveness analysis of Anaprazole versus Ilaprazole for the treatment of duodenal ulcers in China. Front Pharmacol. 2024 Jun 7;15:1407435. doi: 10.3389/fphar.2024.1407435. eCollection 2024. | |
| 36580650 | Derived | Zhu H, Pan X, Zhang L, Sun H, Fan H, Pan Z, Huang C, Shi Z, Ding J, Wang Q, Du Y, Lyu N, Li Z. Effect and safety of anaprazole in the treatment of duodenal ulcers: a randomized, rabeprazole-controlled, phase III non-inferiority study. Chin Med J (Engl). 2022 Dec 20;135(24):2941-2949. doi: 10.1097/CM9.0000000000002508. |
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| Rabeprazole | Drug | administered orally once every 30-60 minutes before breakfast for 4 weeks |
|
| Rabeprazole Placebo | Drug | administered orally once every 30-60 minutes before breakfast for 4 weeks |
|
| Anaprazole Sodium Placebo | Drug | administered orally once every 30-60 minutes before breakfast for 4 weeks |
|
| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| 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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