To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy
Primary Purpose
Gastric Cancer
Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Patients who continued UDCA 300mg medication
Patients who discontinued UDCA 300mg prescription
Sponsored by
About this trial
This is an interventional other trial for Gastric Cancer
Eligibility Criteria
Inclusion Criteria:
- The patient who participated in PEGASUS-D Clinical trial, and is willing to participate in this study by signing the informed consent form.
- Or the patient whose medical records can be accessed according to site's consent exemption criteria.
Exclusion Criteria:
- The patient who the investigator finds it difficult to participate in this clinical trial.
Sites / Locations
- DoJoong ParkRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Patients who received UDCA 600mg
Patients who received UDCA 300mg
Patients who received Placebo
Arm Description
Patients who participated in PEGASUS-D clinical trial and received UDCA 600mg
Patients who participated in PEGASUS-D clinical trial and received UDCA 300mg
Patients who participated in PEGASUS-D clinical trial and received Placebo
Outcomes
Primary Outcome Measures
Proportion of subjects with gallstones formed
The proportion of subjects with gallstones formed after gastrectomy.
Proportion of subjects with gallstones formed
The proportion of subjects with gallstones formed after gastrectomy.
The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
The duration of UDCA
The duration of UDCA
The dose of UDCA
The dose of UDCA
The recurrence rate of gastric cancer
The recurrence rate of gastric cancer
The survival rate of gastric cancer
The survival rate of gastric cancer
Secondary Outcome Measures
Full Information
NCT ID
NCT05410535
First Posted
December 22, 2021
Last Updated
June 6, 2022
Sponsor
Daewoong Pharmaceutical Co. LTD.
1. Study Identification
Unique Protocol Identification Number
NCT05410535
Brief Title
To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy
Official Title
A Multi-center, Phase IV, Extension Study in PEGASUS-D Trial to Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gastrectomy in Patients With Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2021 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
September 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Daewoong Pharmaceutical Co. LTD.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Of those patients who participated in PEGASUS-D FAS clinical trial, patient must sign the informed consent form in order to participate in this extension study.
The medical records of the patients will be reviewed throughout the study.
Detailed Description
Of those patients who participated in PEGASUS-D FAS clinical trial, patient must sign the informed consent form in order to participate in this extension study.
Collection of retrospective cohort data
1)The medical records from the subject's gastrectomy surgery date to Visit1 will be collected through a questionnaire and by reviewing the medical records of the patient.
Collection of prospective cohort data
Based on visit 1, if the subjects whose date of gastrectomy surgery date is more than 3 years(36 months) and less than 5 years(60 months), the subject should visit the institution at the time of 5 years(60 months, visit2) after gastrectomy surgery to evaluate data requested at visit2.
The medical records will be accessed and collected from the subject's gastrectomy surgery date up to 5 years(60 months)
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
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
patients who participated in PEGASUS-D clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
465 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients who received UDCA 600mg
Arm Type
Experimental
Arm Description
Patients who participated in PEGASUS-D clinical trial and received UDCA 600mg
Arm Title
Patients who received UDCA 300mg
Arm Type
Experimental
Arm Description
Patients who participated in PEGASUS-D clinical trial and received UDCA 300mg
Arm Title
Patients who received Placebo
Arm Type
Placebo Comparator
Arm Description
Patients who participated in PEGASUS-D clinical trial and received Placebo
Intervention Type
Drug
Intervention Name(s)
Patients who continued UDCA 300mg medication
Intervention Description
patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial
Intervention Type
Other
Intervention Name(s)
Patients who discontinued UDCA 300mg prescription
Intervention Description
patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial
Primary Outcome Measure Information:
Title
Proportion of subjects with gallstones formed
Description
The proportion of subjects with gallstones formed after gastrectomy.
Time Frame
at 3 years
Title
Proportion of subjects with gallstones formed
Description
The proportion of subjects with gallstones formed after gastrectomy.
Time Frame
at 5 years
Title
The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
Description
The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
Time Frame
at 3 years
Title
The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
Description
The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
Time Frame
at 5 years
Title
The duration of UDCA
Description
The duration of UDCA
Time Frame
up to 5 years
Title
The dose of UDCA
Description
The dose of UDCA
Time Frame
up to 5 years
Title
The recurrence rate of gastric cancer
Description
The recurrence rate of gastric cancer
Time Frame
up to 5 years
Title
The survival rate of gastric cancer
Description
The survival rate of gastric cancer
Time Frame
up to 5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patient who participated in PEGASUS-D Clinical trial, and is willing to participate in this study by signing the informed consent form.
Or the patient whose medical records can be accessed according to site's consent exemption criteria.
Exclusion Criteria:
The patient who the investigator finds it difficult to participate in this clinical trial.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
DoJoong Park
Phone
82-2-2072-1490
Email
dojoongpark@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
DoJoong Park
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
DoJoong Park
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DoJoong Park
Phone
+82220721490
Email
dojoongpark@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy
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