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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02490111
Recruitment Status : Completed
First Posted : July 3, 2015
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
Daewoong Pharmaceutical Co. LTD.

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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: DWJ1319 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 521 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : May 2015
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


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: DWJ1319
Drug: Placebo
Placebo Comparator: Placebo
Placebo, orally, twice daily (BID) for up to 12 months
Drug: Placebo



Primary Outcome Measures :
  1. Proportion of patient developing gallstone at 12 month after gastrectomy [ Time Frame: 12 months ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02490111


Locations
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Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of, 410-769
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, Korea, Republic of, 135-710
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
Sponsors and Collaborators
Daewoong Pharmaceutical Co. LTD.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daewoong Pharmaceutical Co. LTD.
ClinicalTrials.gov Identifier: NCT02490111    
Other Study ID Numbers: DW_UDCA005
First Posted: July 3, 2015    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Stomach Neoplasms
Gallstones
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Cholelithiasis
Biliary Tract Diseases
Cholecystolithiasis
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical