To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy

June 27, 2024 updated by: Daewoong Pharmaceutical Co. LTD.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

    1. 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.
    2. The medical records will be accessed and collected from the subject's gastrectomy surgery date up to 5 years(60 months)

Study Type

Interventional

Enrollment (Actual)

431

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Among the PEGASUS-D Full Analysis Set (FAS) subjects, those who agree to participate in this clinical trial or those who can collect retrospective cohort data after waiving consent according to the consent waiver criteria

Exclusion Criteria:

A person who, at the discretion of the investigator, is deemed difficult to participate in this clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients who received UDCA 600mg
Patients who participated in PEGASUS-D clinical trial and received UDCA 600mg
Drug: Patients who continued UDCA 300mg medication
patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial
Other: Patients who discontinued UDCA 300mg prescription
patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial
Experimental: Patients who received UDCA 300mg
Patients who participated in PEGASUS-D clinical trial and received UDCA 300mg
Drug: Patients who continued UDCA 300mg medication
patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial
Other: Patients who discontinued UDCA 300mg prescription
patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial
Placebo Comparator: Patients who received Placebo
Patients who participated in PEGASUS-D clinical trial and received Placebo
Drug: Patients who continued UDCA 300mg medication
patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial
Other: Patients who discontinued UDCA 300mg prescription
patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with gallstones formed
Time Frame: at 3 years
The proportion of subjects with gallstones formed after gastrectomy.
at 3 years
Proportion of subjects with gallstones formed
Time Frame: at 5 years
The proportion of subjects with gallstones formed after gastrectomy.
at 5 years
The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
Time Frame: at 3 years
The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
at 3 years
The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
Time Frame: at 5 years
The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.
at 5 years
The duration of UDCA
Time Frame: up to 5 years
The duration of UDCA
up to 5 years
The dose of UDCA
Time Frame: up to 5 years
The dose of UDCA
up to 5 years
The recurrence rate of gastric cancer
Time Frame: up to 5 years
The recurrence rate of gastric cancer
up to 5 years
The survival rate of gastric cancer
Time Frame: up to 5 years
The survival rate of gastric cancer
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daewoong Pharmaceutical Co. LTD.

Investigators

  • Principal Investigator: DoJoong Park, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2021

Primary Completion (Actual)

October 28, 2022

Study Completion (Actual)

October 28, 2022

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

June 6, 2022

First Posted (Actual)

June 8, 2022

Study Record Updates

Last Update Posted (Actual)

June 28, 2024

Last Update Submitted That Met QC Criteria

June 27, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DW_UDCA005_P401

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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