Erosive EsophagitisPhase 3NCT03736369
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 3)
A Phase 3 study testing DWP14012 40mg and Esomeprazole 40mg in people with Erosive Esophagitis, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
The purpose of study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- DWP14012 40mg and Esomeprazole 40mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 263 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Dec 2018to 7 Aug 2019
- 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 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 regurgitation 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.
About this study
Official title: A Multi-Center, Randomized, Double-Blind, Active-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease
The purpose of study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.
- Conditions
- Erosive Esophagitis
- Being tested
- DWP14012 40mg, DWP14012 40mg placebo, Esomeprazole 40mg, Esomeprazole 40mg placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012 40mgDrug
DWP14012 40mg, tablet, orally, once daily for up to 8 weeks
DWP14012 40mg placeboDrug
DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
Esomeprazole 40mgDrug
Also called Nexium 40mg
Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks
Esomeprazole 40mg placeboDrug
Also called Nexium 40mg placebo
Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| DWP14012 40mg | Experimental | Orally, once daily Receives: Drug: DWP14012 40mg; Drug: Esomeprazole 40mg placebo |
| Esomeprazole 40mg | Active comparator | Orally, once daily Receives: Drug: DWP14012 40mg placebo; Drug: Esomeprazole 40mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative healing rate of erosive esophagitis at 8week by endoscopy
Measured: at 8week
Secondary outcomes (3)
Cumulative healing rate of erosive esophagitis at 4week by endoscopy
Measured: at 4week
Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
Mean change of the frequency or severity of main symptoms
Measured: at 4week and 8week
Quality of Life assessment using GERD-HRQL(GERD-Health related quality life)
Mean change of the total score of GERD-HRQL
Measured: at 4week and 8week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start13 Dec 2018
- Primary completion7 Aug 2019
- Study completion7 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 263 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
- NCT03736369
- Sponsor's protocol ID
- DW_DWP14012301
- Status last verified
- Sep 2020
- First submitted
- 26 Oct 2018
- Last updated
- 3 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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, Parallel-Group, Phase 3, Therapeutic Confirmatory Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT03736369
- Acronym / sponsor ID
- DW_DWP14012301
- Conditions
- Erosive Esophagitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 263 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 7 Aug 2019 (actual)
- First posted
- 9 Nov 2018 (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 study is to confirm the efficacy of DWP14012 Xmg, Once daily, compared to esomeprazole 40mg in patients with erosive gastroesophageal reflux disease.
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 40mg | Experimental | Drug: DWP14012 40mg, Drug: Esomeprazole 40mg placeboOrally, once daily |
| Esomeprazole 40mg | Active comparator | Drug: DWP14012 40mg placebo, Drug: Esomeprazole 40mgOrally, 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 regurgitation 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 |
|---|---|---|
| DWP14012 40mgDWP14012 40mg, tablet, orally, once daily for up to 8 weeks | Drug | DWP14012 40mg |
| DWP14012 40mg placeboDWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks | Drug | Esomeprazole 40mg |
| Esomeprazole 40mgAlso: Nexium 40mgEsomeprazole 40mg tablet, orally, once daily for up to 8 weeks | Drug | Esomeprazole 40mg |
| Esomeprazole 40mg placeboAlso: Nexium 40mg placeboEsomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks | Drug | DWP14012 40mg |
Primary outcome
Cumulative healing rate of erosive esophagitis at 8week by endoscopy
Time frame: at 8week
3 secondary outcomes
Cumulative healing rate of erosive esophagitis at 4week by endoscopy
Time frame: at 4week
Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
Time frame: at 4week and 8week
Quality of Life assessment using GERD-HRQL(GERD-Health related quality life)
Time frame: at 4week and 8week
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.
- Individual participant dataSharing planned: No
Related trials for Erosive Esophagitis
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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 40mg and Esomeprazole 40mg in people with 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 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 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?
Cumulative healing rate of erosive esophagitis at 8week by endoscopy (time frame: at 8week). 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.