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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DWJ1319
Placebo
Sponsored by
Daewoong Pharmaceutical Co. LTD.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Gastric Cancer

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • National Cancer Center
  • Seoul Natioanl University Bundang Hospital
  • Chonnam National University Hwasun Hospital
  • Pusan National University Yangsan Hospital
  • Kyungpook National university Chilgok Hospital
  • Chungnam National university hospital
  • Samsung Medical Center
  • Asan Medical Center
  • Seoul Metropolitan Government Seoul National University Boramae Medical Center
  • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Yonsei University Severance Hospital
  • Ajou University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

DWJ1319 300 mg BID

DWJ1319 300 mg QD

Placebo

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Proportion of patient developing gallstone at 12 month after gastrectomy

Secondary Outcome Measures

Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy
Time to gallstone formation

Full Information

First Posted
July 1, 2015
Last Updated
February 7, 2019
Sponsor
Daewoong Pharmaceutical Co. LTD.
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1. Study Identification

Unique Protocol Identification Number
NCT02490111
Brief Title
Clinical Trials for the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
521 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DWJ1319 300 mg BID
Arm Type
Experimental
Arm Description
DWJ1319 300 mg, orally, twice daily (BID) for up to 12 months
Arm Title
DWJ1319 300 mg QD
Arm Type
Experimental
Arm Description
DWJ1319 300 mg, orally, once daily (QD), and DWJ1319 placebo-matching capsules, orally, once daily for up to 12 months
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, orally, twice daily (BID) for up to 12 months
Intervention Type
Drug
Intervention Name(s)
DWJ1319
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Proportion of patient developing gallstone at 12 month after gastrectomy
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy
Time Frame
3, 6 and 9 months
Title
Time to gallstone formation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
National Cancer Center
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
410-769
Country
Korea, Republic of
Facility Name
Seoul Natioanl University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Chonnam National University Hwasun Hospital
City
Hwasun
State/Province
Jeollanam-do
Country
Korea, Republic of
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
State/Province
Kyeongsangnamdo
Country
Korea, Republic of
Facility Name
Kyungpook National university Chilgok Hospital
City
Daegu
Country
Korea, Republic of
Facility Name
Chungnam National university hospital
City
Daejeon
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
The Catholic University of Korea, Seoul St. Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Yonsei University Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Ajou University Hospital
City
Suwon
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32584935
Citation
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.
Results Reference
derived

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

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