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NCT Number: NCT02490111

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

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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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

National Cancer Center, Goyang-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DWJ1319

Drug

Placebo

Drug

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

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jul 3, 2015
Registry last updated
Feb 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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