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A phase 2,double-blinded, double dummy, parallel, positive drug, randomised controlled multicenter trial to evaluate efficacy and safety of 4 weeks treatment of Anaprazole 20mg QD, 40mg QD compared with rabeprazole 10mg QD in patients with duodenal ulcers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anaprazole Sodium 20mg QD | Experimental | administered orally once every 30-60 minutes before breakfast for 4 weeks |
|
| Anaprazole Sodium 40mg QD | Experimental | administered orally once every 30-60 minutes before breakfast for 4 weeks |
|
| Rabeprazole sodium 10mg QD | 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 | Anaprazole Sodium 20mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The endoscopic healing rate of duodenal ulcers at week 4. | The endoscopic ulcer healing rate is defined as the percentage of patients with endoscopic ulcer healed evaluated by investigators. | Treatment of 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fisrst Affiliated Hospital of NanChang University | Nanchang | Jiangxi | 330006 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34336894 | Derived | Shu X, Zhu Z, Fu Y, Zhang Z, Wang J, Li X, He S, Fan H, Liu S, Zhang G, Tang J, Huang C, Du Q, Wang X, Xu B, Du Y, Chen Q, Wang B, Chen Y, Duan X, Xie Y, Huo L, Hou X, Lu N. Mucosal Healing Effectiveness and Safety of Anaprazole, a Novel PPI, vs. Rabeprazole in Patients With Duodenal Ulcers: A Randomized Double-Blinded Multicenter Phase II Clinical Trial. Front Med (Lausanne). 2021 Jul 14;8:690995. doi: 10.3389/fmed.2021.690995. eCollection 2021. |
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| ID | Term |
|---|---|
| D064750 | Rabeprazole |
| ID | Term |
|---|---|
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Anaprazole Sodium |
| Drug |
Anaprazole Sodium 40mg |
|
| Rabeprazole sodium | Drug | Rabeprazole sodium 10mg |
|
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001562 | Benzimidazoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |