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

Daewoong Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Gastric Cancer

Treatments: Other: Patients who discontinued UDCA 300mg prescription; Drug: Patients who continued UDCA 300mg medication

Study type: Interventional

Funder types: Industry

Identifiers

NCT05410535

DW_UDCA005_P401

Details and patient eligibility

About

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.

Full 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)

Enrollment: 431 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

431 participants in 3 patient groups, including a placebo group

Patients who received UDCA 600mg

Experimental group

Description:

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

Treatment:

Other: Patients who discontinued UDCA 300mg prescription

Drug: Patients who continued UDCA 300mg medication

Patients who received UDCA 300mg

Experimental group

Description:

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

Treatment:

Other: Patients who discontinued UDCA 300mg prescription

Drug: Patients who continued UDCA 300mg medication

Patients who received Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Patients who discontinued UDCA 300mg prescription

Drug: Patients who continued UDCA 300mg medication