Clinical Trials for the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02490111
• Other study ID #: DW_UDCA005
• Status: Completed
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: January 2018

Study information

• Verified date: February 2019
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 521
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gallstones
• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• DWJ1319

• Placebo

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National university Chilgok Hospital	Daegu
Korea, Republic of	Chungnam National university hospital	Daejeon
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Chonnam National University Hwasun Hospital	Hwasun	Jeollanam-do
Korea, Republic of	Seoul Natioanl University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul
Korea, Republic of	The Catholic University of Korea, Seoul St. Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Severance Hospital	Seoul
Korea, Republic of	Ajou University Hospital	Suwon
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan	Kyeongsangnamdo

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patient developing gallstone at 12 month after gastrectomy		12 months
Secondary	Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy		3, 6 and 9 months
Secondary	Time to gallstone formation		12 months