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

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Criteria

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