Clinical Trials for the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer
- Registration Number
- NCT02490111
- Lead Sponsor
- Daewoong Pharmaceutical Co. LTD.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 521
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DWJ1319 300 mg BID DWJ1319 DWJ1319 300 mg, orally, twice daily (BID) for up to 12 months DWJ1319 300 mg QD DWJ1319 DWJ1319 300 mg, orally, once daily (QD), and DWJ1319 placebo-matching capsules, orally, once daily for up to 12 months DWJ1319 300 mg QD Placebo DWJ1319 300 mg, orally, once daily (QD), and DWJ1319 placebo-matching capsules, orally, once daily for up to 12 months Placebo Placebo Placebo, orally, twice daily (BID) for up to 12 months
- Primary Outcome Measures
Name Time Method Proportion of patient developing gallstone at 12 month after gastrectomy 12 months
- Secondary Outcome Measures
Name Time Method Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy 3, 6 and 9 months Time to gallstone formation 12 months
Trial Locations
- Locations (12)
Yonsei University Severance Hospital
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
National Cancer Center
🇰🇷Goyang-si, Gyeonggi-do, Korea, Republic of
Chonnam National University Hwasun Hospital
🇰🇷Hwasun, Jeollanam-do, Korea, Republic of
Kyungpook National university Chilgok Hospital
🇰🇷Daegu, Korea, Republic of
Chungnam National university hospital
🇰🇷Daejeon, Korea, Republic of
Ajou University Hospital
🇰🇷Suwon, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, Seoul St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Seoul Natioanl University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Seoul Metropolitan Government Seoul National University Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Kyeongsangnamdo, Korea, Republic of