NCT02490111

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
521

participants targeted

Target at P50-P75 for phase_3 gastric-cancer

Timeline
Completed

Started May 2015

Shorter than P25 for phase_3 gastric-cancer

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2015

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

February 8, 2019

Status Verified

February 1, 2019

Enrollment Period

2.7 years

First QC Date

July 1, 2015

Last Update Submit

February 7, 2019

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of patient developing gallstone at 12 month after gastrectomy

    12 months

Secondary Outcomes (2)

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

    3, 6 and 9 months

  • Time to gallstone formation

    12 months

Study Arms (3)

DWJ1319 300 mg BID

EXPERIMENTAL

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

Drug: DWJ1319

DWJ1319 300 mg QD

EXPERIMENTAL

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

Drug: DWJ1319Drug: Placebo

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

DWJ1319DRUG
DWJ1319 300 mg BIDDWJ1319 300 mg QD
PlaceboDRUG
DWJ1319 300 mg QDPlacebo

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Location

Seoul Natioanl University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

Chonnam National University Hwasun Hospital

Hwasun, Jeollanam-do, South Korea

Location

Pusan National University Yangsan Hospital

Yangsan, Kyeongsangnamdo, South Korea

Location

Kyungpook National university Chilgok Hospital

Daegu, South Korea

Location

Chungnam National university hospital

Daejeon, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, South Korea

Location

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Location

Yonsei University Severance Hospital

Seoul, South Korea

Location

Ajou University Hospital

Suwon, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 32584935DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2015

First Posted

July 3, 2015

Study Start

May 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

February 8, 2019

Record last verified: 2019-02

Locations

KR(12)