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CompletedNCT02490111Updated Feb 8, 2019

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

A Phase 3 interventional study of DWJ1319 and Placebo in Gastric Cancer, sponsored by Daewoong Pharmaceutical Co. LTD.. Completed at 12 sites in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2019-02-08.

Sponsored by Daewoong Pharmaceutical Co. LTD. · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
521
Allocation
Randomized
Ages
19 Years and older
Sex
All
01

Study 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.

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Conditions studied

  • Gastric Cancer
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In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 521 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Daewoong Pharmaceutical Co. LTD. is the lead sponsor of 196 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
521 participants (actual)

Study arms

  • 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: DWJ1319 · Drug: Placebo

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugDWJ1319
  • DrugPlacebo
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What researchers measure

Primary outcomes

  1. Proportion of patient developing gallstone at 12 month after gastrectomy

    Time frame: 12 months

Secondary outcomes

  1. Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy

    Time frame: 3, 6 and 9 months

  2. Time to gallstone formation

    Time frame: 12 months

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Study locations

12 sites
  • National Cancer Center
    Goyang-si, Gyeonggi-do 410-769, Korea, Republic of
  • Seoul Natioanl University Bundang Hospital
    Seongnam-si, Gyeonggi-do, Korea, Republic of
  • Chonnam National University Hwasun Hospital
    Hwasun, Jeollanam-do, Korea, Republic of
  • Pusan National University Yangsan Hospital
    Yangsan, Kyeongsangnamdo, Korea, Republic of
  • Kyungpook National university Chilgok Hospital
    Daegu, Korea, Republic of
  • Chungnam National university hospital
    Daejeon, Korea, Republic of
  • Samsung Medical Center
    Seoul, 135-710, Korea, Republic of
  • Asan 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
08

References and documents

Publications

  • Lee SH, Jang DK, Yoo MW, Hwang SH, Ryu SY, Kwon OK, Hur H, Man Yoon H, Eom BW, Ahn HS, Son T, Song KY, Lee HH, Choi MG, An JY, Lee SI, Lee KH, Ahn S, Park YS, Park DJ; 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 (PEGASUS-D) Group. Efficacy and Safety of Ursodeoxycholic Acid for the Prevention of Gallstone Formation After Gastrectomy in Patients With Gastric Cancer: The PEGASUS-D Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):703-711. doi: 10.1001/jamasurg.2020.1501. PubMed 32584935 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 8, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02490111
Lead sponsor
Daewoong Pharmaceutical Co. LTD.
Responsible party
Sponsor
First posted
Jul 3, 2015
Start date
May 2015
Primary completion
Jan 2018
Completion
Jan 2018
Last update
Feb 8, 2019
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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