Gastric CancerPhase 3NCT02490111
Clinical Trials for the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer
A Phase 3 study testing DWJ1319 in people with Gastric Cancer, run by Daewoong Pharmaceutical Co. LTD. at 12 sites in South Korea.
Trial summary
This study evaluates the efficacy and safety of DWJ1319 in the prevention of gallstone formation after gastrectomy in patient with gastric cancer. Two-thirds of the participants will receive DWJ1319, while the other will receive a placebo. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- DWJ1319
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 521 participants
- Where
- 12 sitesSouth Korea
- Study dates
- May 2015to Jan 2018
- Phase
- Phase 3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female at least 19 years of age
- Patient who undergoes gastrectomy (total, distal or proximal gastrectomy)
- D1+ or D2 lymph node dissection
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- Written informed consent
Who cannot join
- Patients with cholangitis, cholecystitis, non-functional gall bladder, or biliary obstruction
- Presence of gallstones on ultrasonography and/or CT
- History of previous cholecystectomy
- Patients undergoing pylorus-preserving gastrectomy
- Pregnant or lactating women and fertile women who is not using proper contraceptive method
- Patients with history of drug or alcohol abuse within 5 years ago
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Kyungpook National university Chilgok Hospital
Daegu
Chungnam National university hospital
Daejeon
National Cancer Center
Goyang-si, Gyeonggi-do, 410-769
Chonnam National University Hwasun Hospital
Hwasun, Jeollanam-do
Seoul Natioanl University Bundang Hospital
Seongnam-si, Gyeonggi-do
Samsung Medical Center
Seoul, 135-710
Asan Medical Center
Seoul
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul
Yonsei University Severance Hospital
Seoul
Ajou University Hospital
Suwon
Pusan National University Yangsan Hospital
Yangsan, Kyeongsangnamdo
About this study
Official title: Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study
This study evaluates the efficacy and safety of DWJ1319 in the prevention of gallstone formation after gastrectomy in patient with gastric cancer. Two-thirds of the participants will receive DWJ1319, while the other will receive a placebo.
- Conditions
- Gastric Cancer
- Being tested
- DWJ1319, Placebo
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1319Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| DWJ1319 300 mg BID | Experimental | DWJ1319 300 mg, orally, twice daily (BID) for up to 12 months Receives: Drug: DWJ1319 |
| DWJ1319 300 mg QD | Experimental | DWJ1319 300 mg, orally, once daily (QD), and DWJ1319 placebo-matching capsules, orally, once daily for up to 12 months Receives: Drug: DWJ1319; Drug: Placebo |
| Placebo | Placebo comparator | Placebo, orally, twice daily (BID) for up to 12 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patient developing gallstone at 12 month after gastrectomy
Measured: 12 months
Secondary outcomes (2)
Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy
Measured: 3, 6 and 9 months
Time to gallstone formation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2018
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 521 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490111
- Sponsor's protocol ID
- DW_UDCA005
- Status last verified
- Feb 2019
- First submitted
- 1 Jul 2015
- Last updated
- 8 Feb 2019
- Results posted
- No
Publications
Lee SH, Jang DK, Yoo MW, Hwang SH, Ryu SY, Kwon OK, Hur H, Man Yoon H, Eom BW, Ahn HS, Son T, Song KY, Lee HH, Choi MG, An JY, Lee SI, Lee KH, Ahn S, Park YS, Park DJ; Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation after Gastrectomy in Patient with Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study (PEGASUS-D) Group. Efficacy and Safety of Ursodeoxycholic Acid for the Prevention of Gallstone Formation After Gastrectomy in Patients With Gastric Cancer: The PEGASUS-D Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):703-711. doi: 10.1001/jamasurg.2020.1501.
PubMed 32584935
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation After Gastrectomy in Patient With Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02490111
- Acronym / sponsor ID
- DW_UDCA005
- Conditions
- Gastric Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 521 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- May 2015 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 3 Jul 2015 (estimated)
- 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.
This study evaluates the efficacy and safety of DWJ1319 in the prevention of gallstone formation after gastrectomy in patient with gastric cancer. Two-thirds of the participants will receive DWJ1319, while the other will receive a placebo.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DWJ1319 300 mg BID | Experimental | Drug: DWJ1319DWJ1319 300 mg, orally, twice daily (BID) for up to 12 months |
| DWJ1319 300 mg QD | Experimental | Drug: DWJ1319, Drug: PlaceboDWJ1319 300 mg, orally, once daily (QD), and DWJ1319 placebo-matching capsules, orally, once daily for up to 12 months |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, orally, twice daily (BID) for up to 12 months |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female at least 19 years of age
- Patient who undergoes gastrectomy (total, distal or proximal gastrectomy)
- D1+ or D2 lymph node dissection
- Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
- Written informed consent
Key exclusion criteria (6 listed)
- Patients with cholangitis, cholecystitis, non-functional gall bladder, or biliary obstruction
- Presence of gallstones on ultrasonography and/or CT
- History of previous cholecystectomy
- Patients undergoing pylorus-preserving gastrectomy
- Pregnant or lactating women and fertile women who is not using proper contraceptive method
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 |
|---|---|---|
| DWJ1319 | Drug | DWJ1319 300 mg BID, DWJ1319 300 mg QD |
| Placebo | Drug | DWJ1319 300 mg QD, Placebo |
Primary outcome
Proportion of patient developing gallstone at 12 month after gastrectomy
Time frame: 12 months
2 secondary outcomes
Proportion of patient developing gallstone at 3, 6 and 9 month after gastrectomy
Time frame: 3, 6 and 9 months
Time to gallstone formation
Time frame: 12 months
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 8 Feb 2019.
- Derived from this study: PubMed 32584935Lee SH, Jang DK, Yoo MW, Hwang SH, Ryu SY, Kwon OK, Hur H, Man Yoon H, Eom BW, Ahn HS, Son T, Song KY, Lee HH, Choi MG, An JY, Lee SI, Lee KH, Ahn S, Park YS, Park DJ; Efficacy and Safety of DWJ1319 in the Prevention of Gallstone Formation after Gastrectomy in Patient with Gastric Cancer: A Multicenter, Randomized, Double-blind, Placebo-controlled Study (PEGASUS-D) Group. Efficacy and Safety of Ursodeoxycholic Acid for the Prevention of Gallstone Formation After Gastrectomy in Patients With Gastric Cancer: The PEGASUS-D Randomized Clinical Trial. JAMA Surg. 2020 Aug 1;155(8):703-711. doi: 10.1001/jamasurg.2020.1501.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DWJ1319 in people with Gastric Cancer, run by Daewoong Pharmaceutical Co. LTD. at 12 sites 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 5 inclusion and 6 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 8 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 patient developing gallstone at 12 month after gastrectomy (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02490111, which also lists 1 linked publication.
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 8 Feb 2019.