NCT05410535

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
431

participants targeted

Target at P50-P75 for phase_4 gastric-cancer

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2022

Completed
Last Updated

June 28, 2024

Status Verified

June 1, 2024

Enrollment Period

1.1 years

First QC Date

December 22, 2021

Last Update Submit

June 27, 2024

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (8)

  • Proportion of subjects with gallstones formed

    The proportion of subjects with gallstones formed after gastrectomy.

    at 3 years

  • Proportion of subjects with gallstones formed

    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.

    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.

    The incidence of symptomatic gallstones, acute cholecystitis, cholangitis, pancreatitis, liver abscess, and cholecystectomy.

    at 5 years

  • The duration of UDCA

    The duration of UDCA

    up to 5 years

  • The dose of UDCA

    The dose of UDCA

    up to 5 years

  • The recurrence rate of gastric cancer

    The recurrence rate of gastric cancer

    up to 5 years

  • The survival rate of gastric cancer

    The survival rate of gastric cancer

    up to 5 years

Study Arms (3)

Patients who received UDCA 600mg

EXPERIMENTAL

Patients who participated in PEGASUS-D clinical trial and received UDCA 600mg

Drug: Patients who continued UDCA 300mg medicationOther: Patients who discontinued UDCA 300mg prescription

Patients who received UDCA 300mg

EXPERIMENTAL

Patients who participated in PEGASUS-D clinical trial and received UDCA 300mg

Drug: Patients who continued UDCA 300mg medicationOther: Patients who discontinued UDCA 300mg prescription

Patients who received Placebo

PLACEBO COMPARATOR

Patients who participated in PEGASUS-D clinical trial and received Placebo

Drug: Patients who continued UDCA 300mg medicationOther: Patients who discontinued UDCA 300mg prescription

Interventions

Patients who continued UDCA 300mg medicationDRUG

patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

Patients who received PlaceboPatients who received UDCA 300mgPatients who received UDCA 600mg
Patients who discontinued UDCA 300mg prescriptionOTHER

patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial

Patients who received PlaceboPatients who received UDCA 300mgPatients who received UDCA 600mg

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DoJoong Park

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Dosage FormsPrescriptions

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsTechnology, PharmaceuticalInvestigative TechniquesPharmaceutical ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • DoJoong Park

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: patients who participated in PEGASUS-D clinical trial
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2021

First Posted

June 8, 2022

Study Start

September 15, 2021

Primary Completion

October 28, 2022

Study Completion

October 28, 2022

Last Updated

June 28, 2024

Record last verified: 2024-06

Locations

KR(1)