Peptic UlcerPhase 3NCT04784910
Study to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer
A Phase 3 study testing DWP14012 20mg and Lansoprazole 15 mg in people with Peptic Ulcer, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The study aims to demonstrate the preventive effect of DWP14012 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of DWP14012 20 mg. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Peptic Ulcer
- What is being tested?
- DWP14012 20mg and Lansoprazole 15 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 423 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 May 2021to 11 Dec 2023
- 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 and female adults aged ≥ 19 years at the time of informed consent
- Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks
- Subjects with at least one of the following risk factors for ulcer development at screening.
- Subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the EGD result at screening.
Who cannot join
- Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results.
- Subjects who have undergone gastroduodenal surgery or total small bowel resection
- Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
- Subjects who have had a malignant tumor in the last 5 years
- Subjects who history of hypersensitivity to the IP ingredients, aspirin and NSAIDs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer
The study aims to demonstrate the preventive effect of DWP14012 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of DWP14012 20 mg.
- Conditions
- Peptic Ulcer
- Being tested
- DWP14012 20mg, Lansoprazole 15 mg, DWP14012 20mg placebo, Lansoprazole 15 mg placebo
- Medical subject headings
- Peptic Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012 20mgDrug
DWP14012 20mg, tablet, orally, once daily for up to 24 weeks
Lansoprazole 15 mgDrug
Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks
DWP14012 20mg placeboDrug
DWP14012 20mg placebo-matching tablet, orally, once daily for up to 24 weeks
Lansoprazole 15 mg placeboDrug
Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| DWP14012 20mg | Experimental | orally, once daily Receives: Drug: DWP14012 20mg; Drug: Lansoprazole 15 mg placebo |
| Lansoprazole 15mg | Active comparator | orally, once daily Receives: Drug: Lansoprazole 15 mg; Drug: DWP14012 20mg placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator
Measured: at 24 weeks
Secondary outcomes (2)
Proportion of subjects who develop peptic ulcer by Week 12 as assessed by investigator
Measured: at 12 weeks
Proportion of subjects with endoscopic gastric or duodenal bleeding** by Week 12 and Week 24
Measured: at 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start21 May 2021
- Primary completion27 Nov 2023
- Study completion11 Dec 2023
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 Peptic UlcerStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 423 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
- NCT04784910
- Sponsor's protocol ID
- DW_DWP14012304
- Status last verified
- Jul 2024
- First submitted
- 3 Mar 2021
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hong S, Ju JH, Lee SH, Hong SJ, Kim SH, Ahn GY, Jung JH, Hur JW, Ha YJ, Park JK, Kim HS, Lee SW, Park YB, Lim MJ, Kim YS, Song JS, Choi CB, Kim SH, Choi IA, Choi KD, Lee TH, Cho YS, Lee YC, Kwon KS, Lee H, Park M, Heo J, Baek S, Lee CK. Comparing the Efficacy and Safety of Fexuprazan and Lansoprazole for the Prevention of Nonsteroidal Anti-inflammatory Drug-Induced Peptic Ulcer. Gut Liver. 2025 Sep 15;19(5):685-695. doi: 10.5009/gnl250019. Epub 2025 Jun 26.
PubMed 40567214
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel-group, Active-controlled, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Prevention of NSAIDs Induced Peptic Ulcer
- ClinicalTrials.gov ID
- NCT04784910
- Acronym / sponsor ID
- DW_DWP14012304
- Conditions
- Peptic Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 423 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 27 Nov 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 5 Mar 2021 (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.
The study aims to demonstrate the preventive effect of DWP14012 20 mg for peptic ulcer is non-inferior to that of Lansoprazole 15 mg in terms of prevention of peptic ulcer and confirm the safety of DWP14012 20 mg.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DWP14012 20mg | Experimental | Drug: DWP14012 20mg, Drug: Lansoprazole 15 mg placeboorally, once daily |
| Lansoprazole 15mg | Active comparator | Drug: Lansoprazole 15 mg, Drug: DWP14012 20mg placeboorally, once daily |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female adults aged ≥ 19 years at the time of informed consent
- Subjects who are diagnosed with musculoskeletal disease at screening and require continued treatment with NSAIDs for at least 24 weeks
- Subjects with at least one of the following risk factors for ulcer development at screening.
- Subjects who have no gastric or duodenal mucosal break or have ulcer in the scarring stage based on the EGD result at screening.
Key exclusion criteria (5 listed)
- Subjects with esophagitis, gastroesophageal varix, esophagus, Barrett's esophagus, acute gastrointestinal bleeding and else based on the screening EGD results.
- Subjects who have undergone gastroduodenal surgery or total small bowel resection
- Subjects with history of clinically significant disease of hepatic, renal, nervous, pulmonary, endocrine, hemato-oncologic, cardiovascular or urinary system
- Subjects who have had a malignant tumor in the last 5 years
- Subjects who history of hypersensitivity to the IP ingredients, aspirin and NSAIDs
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 |
|---|---|---|
| DWP14012 20mgDWP14012 20mg, tablet, orally, once daily for up to 24 weeks | Drug | DWP14012 20mg |
| Lansoprazole 15 mgLansoprazole 15mg capsule, orally, once daily for up to 24 weeks | Drug | Lansoprazole 15mg |
| DWP14012 20mg placeboDWP14012 20mg placebo-matching tablet, orally, once daily for up to 24 weeks | Drug | Lansoprazole 15mg |
| Lansoprazole 15 mg placeboLansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks | Drug | DWP14012 20mg |
Primary outcome
Proportion of subjects who develop peptic ulcer by Week 24 as assessed by investigator
Time frame: at 24 weeks
2 secondary outcomes
Proportion of subjects who develop peptic ulcer by Week 12 as assessed by investigator
Time frame: at 12 weeks
Proportion of subjects with endoscopic gastric or duodenal bleeding** by Week 12 and Week 24
Time frame: at 12, 24 weeks
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 Jul 2024.
- Derived from this study: PubMed 40567214Hong S, Ju JH, Lee SH, Hong SJ, Kim SH, Ahn GY, Jung JH, Hur JW, Ha YJ, Park JK, Kim HS, Lee SW, Park YB, Lim MJ, Kim YS, Song JS, Choi CB, Kim SH, Choi IA, Choi KD, Lee TH, Cho YS, Lee YC, Kwon KS, Lee H, Park M, Heo J, Baek S, Lee CK. Comparing the Efficacy and Safety of Fexuprazan and Lansoprazole for the Prevention of Nonsteroidal Anti-inflammatory Drug-Induced Peptic Ulcer. Gut Liver. 2025 Sep 15;19(5):685-695. doi: 10.5009/gnl250019. Epub 2025 Jun 26.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DWP14012 20mg and Lansoprazole 15 mg in people with Peptic Ulcer, 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 4 inclusion and 5 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 Jul 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. 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 subjects who develop peptic ulcer by Week 24 as assessed by investigator (time frame: at 24 weeks). 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 NCT04784910, 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 Jul 2024.