Erosive Gastroesophageal Reflux DiseasePhase 2NCT03184324
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study)
A Phase 2 study testing DWP14012 and Esomeprazole in people with Erosive Gastroesophageal Reflux Disease, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the efficacy and safety of DWP14012 compared to esomeprazole in the treatment of erosive gastroesophageal reflux disease classified as Los Angeles(LA) classification grades A to D. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Erosive Gastroesophageal Reflux Disease
- What is being tested?
- DWP14012 and Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 211 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Aug 2017to 18 Apr 2018
- Phase
- Phase 2
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults between 20 and 75 years old based on the date of written agreement
- Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
- Those who experienced symptoms of heartburn or acid reflux within the last 7 days
Who cannot join
- Those who have undergone gastric acid suppression or gastric, esophageal surgery
- Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang University Medical Center
Sungdong-gu, Seoul, 04763
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Active-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease.
The purpose of this study is to determine the efficacy and safety of DWP14012 compared to esomeprazole in the treatment of erosive gastroesophageal reflux disease classified as Los Angeles(LA) classification grades A to D.
- Conditions
- Erosive Gastroesophageal Reflux Disease
- Being tested
- DWP14012, Esomeprazole, DWP14012 placebo, Esomeprazole placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012Drug
tablet
EsomeprazoleDrug
Also called Nexium
tablet
DWP14012 placeboDrug
tablet
Esomeprazole placeboDrug
tablet
| Study group | Role | What they receive |
|---|---|---|
| DWP14012 20mg | Experimental | DWP14012 20mg, tablet, orally, once daily Receives: Drug: DWP14012; Drug: DWP14012 placebo; Drug: Esomeprazole placebo |
| DWP14012 40mg | Experimental | DWP14012 40mg, tablet, orally, once daily Receives: Drug: DWP14012; Drug: DWP14012 placebo; Drug: Esomeprazole placebo |
| DWP14012 80mg | Experimental | DWP14012 40mg*2, tablet, orally, once daily Receives: Drug: DWP14012; Drug: DWP14012 placebo; Drug: Esomeprazole placebo |
| Esomerpazole 40mg | Active comparator | Esomerpazole 40mg, tablet, orally, once daily Receives: Drug: Esomeprazole; Drug: DWP14012 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of subjects who were completely cured of mucosal defects by 8 weeks
Measured: 8 weeks
Secondary outcomes (1)
Ratio of subjects who were completely cured of mucosal defects by 4 weeks
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start28 Aug 2017
- Primary completion18 Apr 2018
- Study completion18 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive Gastroesophageal Reflux DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 211 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
- NCT03184324
- Sponsor's protocol ID
- DW_DWP14012002
- Status last verified
- Jun 2018
- First submitted
- 8 Jun 2017
- 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, Randomized, Double-Blind, Active-controlled, Phase 2, Therapeutic Exploratory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease.
- ClinicalTrials.gov ID
- NCT03184324
- Acronym / sponsor ID
- DW_DWP14012002
- Conditions
- Erosive Gastroesophageal Reflux Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 18 Apr 2018 (actual)
- Study completion
- 18 Apr 2018 (actual)
- First posted
- 12 Jun 2017 (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 purpose of this study is to determine the efficacy and safety of DWP14012 compared to esomeprazole in the treatment of erosive gastroesophageal reflux disease classified as Los Angeles(LA) classification grades A to D.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DWP14012 20mg | Experimental | Drug: DWP14012, Drug: DWP14012 placebo, Drug: Esomeprazole placeboDWP14012 20mg, tablet, orally, once daily |
| DWP14012 40mg | Experimental | Drug: DWP14012, Drug: DWP14012 placebo, Drug: Esomeprazole placeboDWP14012 40mg, tablet, orally, once daily |
| DWP14012 80mg | Experimental | Drug: DWP14012, Drug: DWP14012 placebo, Drug: Esomeprazole placeboDWP14012 40mg*2, tablet, orally, once daily |
| Esomerpazole 40mg | Active comparator | Drug: Esomeprazole, Drug: DWP14012 placeboEsomerpazole 40mg, tablet, orally, once daily |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults between 20 and 75 years old based on the date of written agreement
- Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
- Those who experienced symptoms of heartburn or acid reflux within the last 7 days
Key exclusion criteria (2 listed)
- Those who have undergone gastric acid suppression or gastric, esophageal surgery
- Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
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 |
|---|---|---|
| DWP14012tablet | Drug | DWP14012 20mg, DWP14012 40mg, DWP14012 80mg |
| EsomeprazoleAlso: Nexiumtablet | Drug | Esomerpazole 40mg |
| DWP14012 placebotablet | Drug | DWP14012 20mg, DWP14012 40mg, DWP14012 80mg, Esomerpazole 40mg |
| Esomeprazole placebotablet | Drug | DWP14012 20mg, DWP14012 40mg, DWP14012 80mg |
Primary outcome
Ratio of subjects who were completely cured of mucosal defects by 8 weeks
Time frame: 8 weeks
1 secondary outcome
Ratio of subjects who were completely cured of mucosal defects by 4 weeks
Time frame: 4 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 3 Sep 2020.
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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 2 study testing DWP14012 and Esomeprazole in people with Erosive Gastroesophageal Reflux Disease, 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 2 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Ratio of subjects who were completely cured of mucosal defects by 8 weeks (time frame: 8 weeks). 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.