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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Gastric Cancer

Treatments: Drug: DWJ1319; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02490111

DW_UDCA005

Details and patient eligibility

About

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.

Enrollment: 521 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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521 participants in 3 patient groups, including a placebo group

DWJ1319 300 mg BID

Experimental group

Description:

DWJ1319 300 mg, orally, twice daily (BID) for up to 12 months

Treatment:

Drug: DWJ1319

DWJ1319 300 mg QD

Experimental group

Description:

DWJ1319 300 mg, orally, once daily (QD), and DWJ1319 placebo-matching capsules, orally, once daily for up to 12 months

Treatment:

Drug: DWJ1319

Drug: Placebo

Placebo

Placebo Comparator group

Description:

Placebo, orally, twice daily (BID) for up to 12 months

Treatment:

Drug: Placebo