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

February 7, 2019 updated by: Daewoong Pharmaceutical Co. LTD.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

521

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Daegu, Korea, Republic of
        • Kyungpook National University Chilgok Hospital
      • Daejeon, Korea, Republic of
        • Chungnam National University Hospital
      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Yonsei University Severance Hospital
      • Seoul, Korea, Republic of
        • The Catholic University of Korea, Seoul St. Mary's Hospital
      • Seoul, Korea, Republic of
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center
      • Suwon, Korea, Republic of
        • Ajou University Hospital
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
        • National Cancer Center
      • Seongnam-si, Gyeonggi-do, Korea, Republic of
        • Seoul Natioanl University Bundang Hospital
    • Jeollanam-do
      • Hwasun, Jeollanam-do, Korea, Republic of
        • Chonnam National University Hwasun Hospital
    • Kyeongsangnamdo
      • Yangsan, Kyeongsangnamdo, Korea, Republic of
        • Pusan National University Yangsan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DWJ1319 300 mg BID
DWJ1319 300 mg, orally, twice daily (BID) for up to 12 months
Drug: DWJ1319
Experimental: DWJ1319 300 mg QD
DWJ1319 300 mg, orally, once daily (QD), and DWJ1319 placebo-matching capsules, orally, once daily for up to 12 months
Drug: Placebo
Drug: DWJ1319
Placebo Comparator: Placebo
Placebo, orally, twice daily (BID) for up to 12 months
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patient developing gallstone at 12 month after gastrectomy
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy
Time Frame: 3, 6 and 9 months
3, 6 and 9 months
Time to gallstone formation
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

January 1, 2018

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

July 1, 2015

First Submitted That Met QC Criteria

July 1, 2015

First Posted (Estimate)

July 3, 2015

Study Record Updates

Last Update Posted (Actual)

February 8, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_UDCA005

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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