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Non-erosive Reflux DiseasePhase 3NCT06121830

Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non-Erosive Gastroesophageal Reflux Disease (NERD)

A Phase 3 study testing DWP14012 20mg and DWP14012 40mg in people with Non-erosive Reflux Disease and Non-Erosive Gastro-Esophageal Reflux Disease, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is designed to determine the efficacy and safety of DWP14012 compared to a placebo following a once-daily oral dose of DWP14012 at 20 mg, 40 mg, or placebo for 4 weeks in patients with NERD. Read more about this study

Who is it for?
Ages 19 to 75 years
What is being tested?
DWP14012 20mg and DWP14012 40mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
324 participants
Where
1 siteSouth Korea
Study dates
31 Aug 2023to Mar 2025
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, both inclusive, at the date of obtaining informed consent
  • Subjects with no mucosal break(s) according to Los-Angeles grade on EGD performed at the same site within 2 weeks prior to Visit 1
  • Subjects who have experienced heartburn for at least 12 weeks prior to Visit 1
  • Subjects who have completed all symptom assessments (heartburn, acid regurgitation) in the subject diary from 7 days to 1 day prior to Visit 2
  • Subjects who have experienced one of the following symptoms according to the symptom assessments in the subject diary from 7 days to 1 day prior to Visit 2
  • Subjects who have reported at least moderate burning sensation in the esophagus (behind the breastbone) for heartburn symptoms for at least 4 days
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  • Subjects who have reported at least moderate pain in the esophagus (behind the breastbone) for heartburn symptoms for at least 4 days
  • Subjects who are capable of understanding the provided information and able to comply with all the study procedures including filling out the subject diary and questionnaire throughout the study
  • Subjects who voluntarily decide to participate in the study and sign the informed consent form

Who cannot join

  • Subjects who have Barrett's esophagus, gastroesophageal varix, viral/fungal gastrointestinal infection, esophagostenosis, ulcer stenosis, active peptic ulcer, gastrointestinal bleeding, or a malignant tumor identified on EGD performed within 2 weeks prior to Visit 1
  • Subjects who have warning symptoms of malignant gastrointestinal tract diseases such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or hematochezia at Visit 1 (However subjects who have additional warning symptoms besides typical symptoms of gastroesophageal reflux disease [GERD] may be included if the result of endoscopy, etc. is negative for the presence of tumor.)
  • Subjects with Zollinger-Ellison syndrome at Visit 1
  • Subjects with eosinophilic esophagitis at Visit 1
  • Subjects who are diagnosed with erosive GERD, acute upper gastrointestinal bleeding, gastric ulcer, or duodenal ulcer within 8 weeks prior to Visit 1
  • Subjects who are diagnosed with FD, FH, RH, primary esophageal motility disorder, IBS, and IBD within 12 weeks prior to Visit 1
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  • Subjects who had a surgery to reduce gastric acid secretion, or gastric or esophageal surgery (e.g., gastrectomy, mucosal resection, etc.) (Except, simple perforation surgery and endoscopic resection of benign tumors)
  • Subjects who have a clinically significant disease of hepatic, renal, neurologic, respiratory, endocrine, hemato-oncologic, cardiovascular or urinary system at Visit 1
  • Subjects who have history of alcohol or other drug abuse within 1 year prior to Visit 1
  • Subjects diagnosed with malignant tumor within 5 years prior to Visit 1 (Subjects completely healed for ≥5 years from the last treatment without recurrence are allowed to be enrolled.)
  • Subjects with cured basal cell carcinoma of the skin or carcinoma in situ of the cervix are allowed to be enrolled regardless of time period
  • Subjects with a history of digestive malignant tumor are excluded regardless of the time period
  • Subjects who have or had bipolar disorder, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other clinically significant psychiatric disorders
  • Subjects with scleroderma (systemic sclerosis) or systemic lupus erythematosus
  • Subjects who have hypersensitivity, or medical history of clinically significant hypersensitivity, to any components of the IP
  • Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • Wonkwang University Hospital

    Iksan, Jeollabuk-do, 54538

    Suck Chei Choi, 063-859-2563, medcsc@wkuh.org

    Recruiting

Other trials in South Korea

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

This study is designed to determine the efficacy and safety of DWP14012 compared to a placebo following a once-daily oral dose of DWP14012 at 20 mg, 40 mg, or placebo for 4 weeks in patients with NERD.

Being tested
DWP14012 20mg, DWP14012 40mg, Placebo
Keywords
NERD
Medical subject headings
Non-Erosive Reflux Disease

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 4 weeks

  • DWP14012 40mgDrug

    DWP14012 40mg, tablet, orally, once daily for up to 4 weeks

  • PlaceboDrug

    Placebo, tablet, orally, once daily for up to 4 weeks

Study groups in NCT06121830
Study groupRoleWhat they receive
DWP14012 20mgExperimentalOnce daily with water regardless of meals without chewing or crushing for 4 weeks.
Receives: Drug: DWP14012 20mg
DWP14012 40mgExperimentalOnce daily with water regardless of meals without chewing or crushing for 4 weeks.
Receives: Drug: DWP14012 40mg
PlaceboPlacebo comparatorOnce daily with water regardless of meals without chewing or crushing for 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 heartburn-free days for 4 weeks (daytime/nighttime)

    Measured: 4 Weeks

Secondary outcomes (1)

  1. Percentage of major symptom-free (heartburn, acid regurgitation, or heartburn/acid regurgitation) days for 2 and 4 weeks (daytime/nighttime, daytime and nighttime)

    Measured: 4 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2023
  2. Study start31 Aug 2023
  3. Primary completionJan 2025 (estimated)
  4. Study completionMar 2025 (estimated)

Resources

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
Double blind
Who is masked
Participant, Investigator
Enrolment
324 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06121830
Sponsor's protocol ID
DW_DWP14012311
Status last verified
Nov 2023
First submitted
16 Oct 2023
Last updated
8 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DWP14012 20mg and DWP14012 40mg in people with Non-erosive Reflux Disease and Non-Erosive Gastro-Esophageal 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 9 inclusion and 16 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 8 Nov 2023. 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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of heartburn-free days for 4 weeks (daytime/nighttime) (time frame: 4 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 NCT06121830.

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 Nov 2023.

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