Healed Erosive EsophagitisPhase 3NCT04341428
Study to Evaluate the Efficacy and Safety of DWP14012 on Maintaining Healing in Subjects With Healed Erosive Esophagitis
A Phase 3 study testing DWP14012 20 mg and Lansoprazole 15 mg in people with Healed Erosive Esophagitis, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study aims to demonstrate the noninferiority of DWP14012 to Lansoprazole 15 mg in the maintenance effect of treatment and confirm the safety of DWP14012 in patients with healed erosive esophagitis confirmed on EGD after medication treatment. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Healed Erosive Esophagitis
- What is being tested?
- DWP14012 20 mg 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
- 406 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Jul 2020to 30 Dec 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female adults aged 19 to 75 years, at the date the written informed consent form is signed
- Subjects with erosive esophagitis (LA Grade A-D) confirmed on EGD within 12 weeks from Visit 2 (randomization day)
- Subjects with healed erosive esophagitis (no mucosal break observed according to LA classification) confirmed on EGD performed within 10 days before Visit 2 (randomization day) after receiving the standard dose of medicinal products of erosive esophagitis (PPI, P-CAB, etc.) for 4 to 8 weeks for the treatment of erosive esophagitis
Who cannot join
- Subjects who have Barrett's esophagus (> 3 cm), gastroesophageal varix, esophagostenosis, ulcer stenosis, active peptic ulcer, acute gastrointestinal bleeding, or a malignant tumor upon EGD screening
- Subjects who have inflammatory bowel disease (Crohn disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility, or pancreatitis.
- 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 must continue to take non-steroidal anti-inflammatory drugs (aspirin, etc.), antithrombotic drugs, etc. during the study period (A low dose of aspirin [100 mg/day] which has been administered for prophylactic purpose before study entry is allowed)
- Subjects who cannot stop the existing erosive esophagitis treatment being taken
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
The Catholic University of Korea, Yeouido ST. Mary's Hospital
Seoul, 07345
JINIL KIM, M.D., Ph.D.
About this study
Official title: A Multi-center, Double-Blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 as Maintenance Therapy in Patients With Healed Erosive Esophagitis
This study aims to demonstrate the noninferiority of DWP14012 to Lansoprazole 15 mg in the maintenance effect of treatment and confirm the safety of DWP14012 in patients with healed erosive esophagitis confirmed on EGD after medication treatment.
- Conditions
- Healed Erosive Esophagitis
- Being tested
- DWP14012 20 mg, DWP14012 20 mg placebo, Lansoprazole 15 mg, Lansoprazole 15 mg Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012 20 mgDrug
DWP14012 20 mg, tablet, orally, once daily for up to 24 weeks
DWP14012 20 mg placeboDrug
DWP14012 20 mg placebo-matching tablet, orally, once daily for up to 24 weeks
Lansoprazole 15 mgDrug
Lansoprazole 15 mg capsule, orally, once daily for up to 24 weeks
Lansoprazole 15 mg PlaceboDrug
Lansoprazole 15 mg Placebo capsule, orally, once daily for up to 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| DWP14012 20mg | Experimental | Orally, once daily Receives: Drug: DWP14012 20 mg; Drug: Lansoprazole 15 mg Placebo |
| Lansoprazole 15mg | Active comparator | Orally, once daily Receives: Drug: DWP14012 20 mg placebo; Drug: Lansoprazole 15 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24
Measured: at 24 week
Secondary outcomes (1)
Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 12
Measured: at 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start2 Jul 2020
- Primary completion30 Aug 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healed Erosive EsophagitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 406 participants (estimated)
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
- NCT04341428
- Sponsor's protocol ID
- DW_DWP14012303
- Status last verified
- Jul 2020
- First submitted
- 9 Apr 2020
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-Blind, Randomized, Active-controlled, Parallel-group, Phase III Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 as Maintenance Therapy in Patients With Healed Erosive Esophagitis
- ClinicalTrials.gov ID
- NCT04341428
- Acronym / sponsor ID
- DW_DWP14012303
- Conditions
- Healed Erosive Esophagitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 406 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 Aug 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 10 Apr 2020 (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.
This study aims to demonstrate the noninferiority of DWP14012 to Lansoprazole 15 mg in the maintenance effect of treatment and confirm the safety of DWP14012 in patients with healed erosive esophagitis confirmed on EGD after medication treatment.
Study design
- Primary purpose
- Treatment
- 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 20 mg, Drug: Lansoprazole 15 mg PlaceboOrally, once daily |
| Lansoprazole 15mg | Active comparator | Drug: DWP14012 20 mg placebo, Drug: Lansoprazole 15 mgOrally, once daily |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male and female adults aged 19 to 75 years, at the date the written informed consent form is signed
- Subjects with erosive esophagitis (LA Grade A-D) confirmed on EGD within 12 weeks from Visit 2 (randomization day)
- Subjects with healed erosive esophagitis (no mucosal break observed according to LA classification) confirmed on EGD performed within 10 days before Visit 2 (randomization day) after receiving the standard dose of medicinal products of erosive esophagitis (PPI, P-CAB, etc.) for 4 to 8 weeks for the treatment of erosive esophagitis
Key exclusion criteria (6 listed)
- Subjects who have Barrett's esophagus (> 3 cm), gastroesophageal varix, esophagostenosis, ulcer stenosis, active peptic ulcer, acute gastrointestinal bleeding, or a malignant tumor upon EGD screening
- Subjects who have inflammatory bowel disease (Crohn disease, ulcerative colitis, etc.), irritable bowel syndrome (IBS), primary esophageal motility, or pancreatitis.
- 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 must continue to take non-steroidal anti-inflammatory drugs (aspirin, etc.), antithrombotic drugs, etc. during the study period (A low dose of aspirin [100 mg/day] which has been administered for prophylactic purpose before study entry is allowed)
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 20 mgDWP14012 20 mg, tablet, orally, once daily for up to 24 weeks | Drug | DWP14012 20mg |
| DWP14012 20 mg placeboDWP14012 20 mg placebo-matching tablet, orally, once daily for up to 24 weeks | Drug | Lansoprazole 15mg |
| Lansoprazole 15 mgLansoprazole 15 mg capsule, orally, once daily for up to 24 weeks | Drug | Lansoprazole 15mg |
| Lansoprazole 15 mg PlaceboLansoprazole 15 mg Placebo capsule, orally, once daily for up to 24 weeks | Drug | DWP14012 20mg |
Primary outcome
Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24
Time frame: at 24 week
1 secondary outcome
Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 12
Time frame: at 12 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
Related trials for Healed Erosive Esophagitis
Not yet recruitingPhase 3
Efficacy and Safety of DWP14012 for Long-Term Maintenance Therapy in Patients With Healed Erosive Esophagitis
Healed Erosive Esophagitis
Not yet recruitingPhase 3
Phase 3 Study of JP-1366: Efficacy and Safety of JP-1366 as Maintenance Therapy in Subjects With Healed Erosive Esophagitis
Maintenance of Healed Erosive Gastroesophageal Reflux Disease (ERD)
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.
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 20 mg and Lansoprazole 15 mg in people with Healed Erosive Esophagitis, 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 3 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: status not confirmed, as of the sponsor's last update on 3 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oh-Young Lee (82-2-2290-8637, leeoy@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion (%) of subjects with remission maintained on esophagogastroduodenoscopy by Week 24 (time frame: at 24 week). 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 3 Sep 2020.