Gastric CancerPhase 4NCT05410535
To Evaluate Efficacy of Ursodeoxycholic Acid (UDCA) for the Prevention of Gallstone Formation After Gasterectomy
A Phase 4 study testing Patients who continued UDCA 300mg medication and Patients who discontinued UDCA 300mg prescription in people with Gastric Cancer, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Patients who continued UDCA 300mg medication and Patients who discontinued UDCA 300mg prescription
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 431 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Sep 2021to 28 Oct 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- A person who, at the discretion of the investigator, is deemed difficult to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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)
- Conditions
- Gastric Cancer
- Being tested
- Patients who continued UDCA 300mg medication, Patients who discontinued UDCA 300mg prescription
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients who continued UDCA 300mg medicationDrug
patients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial
Patients who discontinued UDCA 300mg prescriptionOther
patients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial
| Study group | Role | What they receive |
|---|---|---|
| Patients who received UDCA 600mg | Experimental | Patients who participated in PEGASUS-D clinical trial and received UDCA 600mg Receives: Drug: Patients who continued UDCA 300mg medication; Other: Patients who discontinued UDCA 300mg prescription |
| Patients who received UDCA 300mg | Experimental | Patients who participated in PEGASUS-D clinical trial and received UDCA 300mg Receives: Drug: Patients who continued UDCA 300mg medication; Other: Patients who discontinued UDCA 300mg prescription |
| Patients who received Placebo | Placebo comparator | Patients who participated in PEGASUS-D clinical trial and received Placebo Receives: Drug: Patients who continued UDCA 300mg medication; Other: Patients who discontinued UDCA 300mg prescription |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with gallstones formed
The proportion of subjects with gallstones formed after gastrectomy.
Measured: at 3 years
Proportion of subjects with gallstones formed
The proportion of subjects with gallstones formed after gastrectomy.
Measured: 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.
Measured: 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.
Measured: at 5 years
The duration of UDCA
The duration of UDCA
Measured: up to 5 years
The dose of UDCA
The dose of UDCA
Measured: up to 5 years
The recurrence rate of gastric cancer
The recurrence rate of gastric cancer
Measured: up to 5 years
The survival rate of gastric cancer
The survival rate of gastric cancer
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start15 Sep 2021
- Primary completion28 Oct 2022
- Study completion28 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- patients who participated in PEGASUS-D clinical trial
- Masking
- None (open label)
- Enrolment
- 431 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- DoJoong Park, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410535
- Sponsor's protocol ID
- DW_UDCA005_P401
- Status last verified
- Jun 2024
- First submitted
- 22 Dec 2021
- Last updated
- 28 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05410535
- Acronym / sponsor ID
- DW_UDCA005_P401
- Conditions
- Gastric Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 431 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- 28 Oct 2022 (actual)
- Study completion
- 28 Oct 2022 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- patients who participated in PEGASUS-D clinical trial
| Arm | Type | Receives |
|---|---|---|
| Patients who received UDCA 600mg | Experimental | Drug: Patients who continued UDCA 300mg medication, Other: Patients who discontinued UDCA 300mg prescriptionPatients who participated in PEGASUS-D clinical trial and received UDCA 600mg |
| Patients who received UDCA 300mg | Experimental | Drug: Patients who continued UDCA 300mg medication, Other: Patients who discontinued UDCA 300mg prescriptionPatients who participated in PEGASUS-D clinical trial and received UDCA 300mg |
| Patients who received Placebo | Placebo comparator | Drug: Patients who continued UDCA 300mg medication, Other: Patients who discontinued UDCA 300mg prescriptionPatients who participated in PEGASUS-D clinical trial and received Placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- A person who, at the discretion of the investigator, is deemed difficult to participate in this clinical trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients who continued UDCA 300mg medicationpatients who continued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial | Drug | Patients who received Placebo, Patients who received UDCA 300mg, Patients who received UDCA 600mg |
| Patients who discontinued UDCA 300mg prescriptionpatients who discontinued UDCA 300mg prescription for the prevention of gallstone after PEGASUS-d trial | Other | Patients who received Placebo, Patients who received UDCA 300mg, Patients who received UDCA 600mg |
Primary outcome
Proportion of subjects with gallstones formed
Time frame: at 3 years
The proportion of subjects with gallstones formed after gastrectomy.
Proportion of subjects with gallstones formed
Time frame: at 5 years
The proportion of subjects with gallstones formed after gastrectomy.
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.
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.
The duration of UDCA
Time frame: up to 5 years
The duration of UDCA
The dose of UDCA
Time frame: up to 5 years
The dose of UDCA
The recurrence rate of gastric cancer
Time frame: up to 5 years
The recurrence rate of gastric cancer
The survival rate of gastric cancer
Time frame: up to 5 years
The survival rate of gastric cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DoJoong Park principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Patients who continued UDCA 300mg medication and Patients who discontinued UDCA 300mg prescription in people with Gastric Cancer, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with gallstones formed (time frame: at 3 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2024.