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The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with erosive gastroesphageal reflux disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIP1601+HGP1705 Placebo | Experimental | HIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks |
|
| HGP1705+HIP1601 Placebo | Experimental | HGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HIP1601 | Drug | Oral esomeprazole |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete healing rate | percentage of subjects whose erosion is completely cured | at 4 weeks or 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complete healing rate | percentage of subjects whose erosion is completely cured | at 4 weeks |
| Complete resolution rate of each symptom in GERD | at 4,8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hunyong Jung, MD, Ph.D. | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38110901 | Derived | Lim H, Park JK, Chung H, Lee SH, Park JM, Park JH, Kim GH, Shin SK, Hong SJ, Lee KJ, Park MI, Jung HK, Kim HS, Sung JK, Jeon SW, Choi SC, Moon JS, Kim N, Park JJ, Hong SH, Kim NY, Jung HY. Efficacy and safety of HIP1601 (dual delayed-release esomeprazole) 40 mg in erosive esophagitis compared to HGP1705 (delayed-release esomeprazole) 40 mg: a multicenter, randomized, double-blind, non-inferiority study. BMC Gastroenterol. 2023 Dec 18;23(1):447. doi: 10.1186/s12876-023-03087-6. |
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| ID | Term |
|---|---|
| D064098 | Esomeprazole |
| ID | Term |
|---|---|
| D009853 | Omeprazole |
| D053799 | 2-Pyridinylmethylsulfinylbenzimidazoles |
| D013454 | Sulfoxides |
| D013457 | Sulfur Compounds |
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multicenter, randomized, double-blind, parallel group study
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double-blind
| HGP1705 | Drug | Oral Nexium Tab |
|
|
| HIP1601 Placebo | Drug | Oral Placebo |
|
| HGP1705 Placebo | Drug | Oral Placebo |
|
| Proportion of heartburn-free days, acid regurgitation-free days | at 1, 2, 4, 8 weeks |
| Proportion of heartburn-free nights, acid regurgitation-free nights | at 1, 2, 4, 8 weeks |
| Time to sustained resolution heartburn, acid regurgitation | at 4 weeks or 8 weeks |
| Time to sustained resolution of nocturnal heartburn, nocturnal acid regurgitation | at 4 weeks or 8 weeks |
| Total number of use of relief drugs and average usage per day | at 4 weeks or 8 weeks |
| 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 |