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This study evaluates the efficacy and safety of DWJ1319 in the prevention of gallstone formation after gastrectomy in patient with gastric cancer. Two-thirds of the participants will receive DWJ1319, while the other will receive a placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWJ1319 300 mg BID | Experimental | DWJ1319 300 mg, orally, twice daily (BID) for up to 12 months |
|
| DWJ1319 300 mg QD | Experimental | DWJ1319 300 mg, orally, once daily (QD), and DWJ1319 placebo-matching capsules, orally, once daily for up to 12 months |
|
| Placebo | Placebo Comparator | Placebo, orally, twice daily (BID) for up to 12 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWJ1319 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patient developing gallstone at 12 month after gastrectomy | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy | 3, 6 and 9 months | |
| Time to gallstone formation | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Center | Goyang-si | Gyeonggi-do | 410-769 | South Korea | ||
| Seoul Natioanl University Bundang Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32584935 | Derived | Lee SH, Jang DK, Yoo MW, Hwang SH, Ryu SY, Kwon OK, Hur H, Man Yoon H, Eom BW, Ahn HS, Son T, Song KY, Lee HH, Choi MG, An JY, Lee SI, Lee KH, Ahn S, Park YS, Park DJ; Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation after Gastrectomy in Patient with Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study (PEGASUS-D) Group. Efficacy and Safety of Ursodeoxycholic Acid for the Prevention of Gallstone Formation After Gastrectomy in Patients With Gastric Cancer: The PEGASUS-D Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):703-711. doi: 10.1001/jamasurg.2020.1501. |
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|
| Seongnam-si |
| Gyeonggi-do |
| South Korea |
| Chonnam National University Hwasun Hospital | Hwasun | Jeollanam-do | South Korea |
| Pusan National University Yangsan Hospital | Yangsan | Kyeongsangnamdo | South Korea |
| Kyungpook National university Chilgok Hospital | Daegu | South Korea |
| Chungnam National university hospital | Daejeon | South Korea |
| Samsung Medical Center | Seoul | 135-710 | South Korea |
| Asan Medical Center | Seoul | South Korea |
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Seoul | South Korea |
| The Catholic University of Korea, Seoul St. Mary's Hospital | Seoul | South Korea |
| Yonsei University Severance Hospital | Seoul | South Korea |
| Ajou University Hospital | Suwon | South Korea |
| ID | Term |
|---|---|
| D013274 | Stomach Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
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