Non-Erosive Gastroesophageal Reflux DiseasePhase 3NCT03811080
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non Erosive Reflux Disease
A Phase 3 study testing DWP14012 A mg and DWP14012 B mg in people with Non-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 demonstrate the superiority of efficacy of DWP14012, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Non-Erosive Gastroesophageal Reflux Disease
- What is being tested?
- DWP14012 A mg and DWP14012 B mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 327 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Feb 2019to Feb 2020
- 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
- Subjects aged between 20 and 75 years
- Subjects who were not observed mucosal break according to the LA classification(LA grade) on the EGD
- Subjects who had experienced major symptom within 3 months
- Subjects who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week
- Subjects who is able to understand and follow the instructions
- Subjects who voluntarily signed written informed consent form
Who cannot join
- Subjects who have Barrett's esophagus, gastroesophageal varices, esophageal stenosis, ulcer stenosis, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by endoscopy
- Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers within 2 months before Visit 1
- Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD in the last 3 months
- Subjects who have a history of gastric acid suppression surgery or gastroesophageal surgery
- Subjects with Zollinger-Ellison syndrome
- Subjects with eosinophilic esophagitis
- Subjects with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease .
Trial locations and contacts
1 site in 1 country.
Daewoong Pharmaceutical Co. LTD. contact
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University Medical Center
Seoul
Ohyoung Lee, 82-2-2290-9652, irb@hyumc.com
Ohoyoung Lee
About this study
Official title: A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non-Erosive Gastroesophageal Reflux Disease
The purpose of this study is to demonstrate the superiority of efficacy of DWP14012, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4.
Read the detailed description
This is a multi-center, double blind, randomized, placebo-controlled, parallel-group, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (DWP14012 A mg or DWP14012 B mg or placebo).
- Being tested
- DWP14012 A mg, DWP14012 B mg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWP14012 A mgDrug
The participants will receive treatment of DWP14012 A mg, tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.
DWP14012 B mgDrug
The participants will receive treatment of DWP14012 B mg, tablet, orally, once daily and DWP14012 A mg placebo-matching tablet, orally, once daily for up to 4 weeks.
PlaceboDrug
The participants will receive treatment of DWP14012 A mg placebo-matching tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| DWP14012 A mg | Experimental | DWP14012 A mg, tablet, once daily, oral administration for up to 4 weeks Receives: Drug: DWP14012 A mg |
| DWP14012 B mg | Experimental | DWP14012 B mg, tablet, once daily, oral administration for up to 4 weeks Receives: Drug: DWP14012 B mg |
| Placebo | Placebo comparator | Placebo, tablet, once daily, oral administration for up to 4 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week
defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ)
Measured: 4 week
Secondary outcomes (4)
Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
Measured: 2 week, 4 week
Reflux disease symptom assessment using Subject diary
Measured: 4 week
Quality of Life assessment using PAGI-QoL
Measured: 4 week
Use of rescue medication
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start7 Feb 2019
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 327 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
- NCT03811080
- Sponsor's protocol ID
- DW_DWP14012302
- Status last verified
- Jun 2019
- First submitted
- 17 Jan 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-Group, Phase 3, Therapeutic Confirmatory Clinical Trial to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non-Erosive Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT03811080
- Acronym / sponsor ID
- DW_DWP14012302
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 327 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 7 Feb 2019 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 22 Jan 2019 (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 demonstrate the superiority of efficacy of DWP14012, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4.
Detailed description
This is a multi-center, double blind, randomized, placebo-controlled, parallel-group, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (DWP14012 A mg or DWP14012 B mg or placebo).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DWP14012 A mg | Experimental | Drug: DWP14012 A mgDWP14012 A mg, tablet, once daily, oral administration for up to 4 weeks |
| DWP14012 B mg | Experimental | Drug: DWP14012 B mgDWP14012 B mg, tablet, once daily, oral administration for up to 4 weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo, tablet, once daily, oral administration for up to 4 weeks |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects aged between 20 and 75 years
- Subjects who were not observed mucosal break according to the LA classification(LA grade) on the EGD
- Subjects who had experienced major symptom within 3 months
- Subjects who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week
- Subjects who is able to understand and follow the instructions
Key exclusion criteria (7 listed)
- Subjects who have Barrett's esophagus, gastroesophageal varices, esophageal stenosis, ulcer stenosis, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by endoscopy
- Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers within 2 months before Visit 1
- Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD in the last 3 months
- Subjects who have a history of gastric acid suppression surgery or gastroesophageal surgery
- Subjects with Zollinger-Ellison syndrome
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 A mgThe participants will receive treatment of DWP14012 A mg, tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks. | Drug | DWP14012 A mg |
| DWP14012 B mgThe participants will receive treatment of DWP14012 B mg, tablet, orally, once daily and DWP14012 A mg placebo-matching tablet, orally, once daily for up to 4 weeks. | Drug | DWP14012 B mg |
| PlaceboThe participants will receive treatment of DWP14012 A mg placebo-matching tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks. | Drug | Placebo |
Primary outcome
1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week
Time frame: 4 week
defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ)
4 secondary outcomes
Reflux disease symptom assessment using RDQ(Reflux disease questionnaire)
Time frame: 2 week, 4 week
Reflux disease symptom assessment using Subject diary
Time frame: 4 week
Quality of Life assessment using PAGI-QoL
Time frame: 4 week
Use of rescue medication
Time frame: 4 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
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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.
Daewoong Pharmaceutical Co. LTD. contact
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 A mg and DWP14012 B mg in people with Non-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 6 inclusion and 7 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 25 Jun 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daewoong Pharmaceutical Co. LTD., or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Percentage of patients with complete resolution of major symptoms (heartburn and acid regurgitation) at 4-week (time frame: 4 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 25 Jun 2019.