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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

521 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DWJ1319 300 mg BID

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

Group Type EXPERIMENTAL

DWJ1319

Intervention Type DRUG

DWJ1319 300 mg QD

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

Group Type EXPERIMENTAL

DWJ1319

Intervention Type DRUG

Placebo

Intervention Type DRUG

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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DWJ1319

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No