Clinical trial · Interventional
Clinical Trials for the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer
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
NCT02490111CI-TRIAL-00037006completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DWJ1319 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- DWJ1319 300 mg BID
- description
- DWJ1319 300 mg, orally, twice daily (BID) for up to 12 months
- interventionNames
- Drug: DWJ1319
- type
- EXPERIMENTAL
- label
- DWJ1319 300 mg QD
- description
- DWJ1319 300 mg, orally, once daily (QD), and DWJ1319 placebo-matching capsules, orally, once daily for up to 12 months
- interventionNames
- Drug: DWJ1319
- Drug: Placebo
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo, orally, twice daily (BID) for up to 12 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female at least 19 years of age * Patient who undergoes gastrectomy (total, distal or proximal gastrectomy) * D1+ or D2 lymph node dissection * Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale * Written informed consent Exclusion Criteria: * Patients with cholangitis, cholecystitis, non-functional gall bladder, or biliary obstruction * Presence of gallstones on ultrasonography and/or CT * History of previous cholecystectomy * Patients undergoing pylorus-preserving gastrectomy * Pregnant or lactating women and fertile women who is not using proper contraceptive method * Patients with history of drug or alcohol abuse within 5 years ago
References
Publications (1)
- DERIVEDLee 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. PMID 32584935