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

November 6, 2023 updated by: Daewoong Pharmaceutical Co. LTD.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
324

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Jeollabuk-do
      • Iksan, Jeollabuk-do, Korea, Republic of, 54538
        • Recruiting
        • Wonkwang University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female adults aged 19 to 75 years, both inclusive, at the date of obtaining informed consent
  2. 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
  3. Subjects who have experienced heartburn for at least 12 weeks prior to Visit 1
  4. Subjects who have completed all symptom assessments (heartburn, acid regurgitation) in the subject diary from 7 days to 1 day prior to Visit 2
  5. 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
  6. Subjects who have reported at least moderate burning sensation in the esophagus (behind the breastbone) for heartburn symptoms for at least 4 days
  7. Subjects who have reported at least moderate pain in the esophagus (behind the breastbone) for heartburn symptoms for at least 4 days
  8. 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
  9. Subjects who voluntarily decide to participate in the study and sign the informed consent form

Exclusion Criteria:

  1. 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
  2. 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.)
  3. Subjects with Zollinger-Ellison syndrome at Visit 1
  4. Subjects with eosinophilic esophagitis at Visit 1
  5. Subjects who are diagnosed with erosive GERD, acute upper gastrointestinal bleeding, gastric ulcer, or duodenal ulcer within 8 weeks prior to Visit 1
  6. Subjects who are diagnosed with FD, FH, RH, primary esophageal motility disorder, IBS, and IBD within 12 weeks prior to Visit 1
  7. 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)
  8. Subjects who have a clinically significant disease of hepatic, renal, neurologic, respiratory, endocrine, hemato-oncologic, cardiovascular or urinary system at Visit 1
  9. Subjects who have history of alcohol or other drug abuse within 1 year prior to Visit 1

  10. 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
  11. Subjects who have or had bipolar disorder, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other clinically significant psychiatric disorders
  12. Subjects with scleroderma (systemic sclerosis) or systemic lupus erythematosus
  13. Subjects who have hypersensitivity, or medical history of clinically significant hypersensitivity, to any components of the IP
  14. Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DWP14012 20mg
Once daily with water regardless of meals without chewing or crushing for 4 weeks.
Drug: DWP14012 20mg
DWP14012 20mg, tablet, orally, once daily for up to 4 weeks
Experimental: DWP14012 40mg
Once daily with water regardless of meals without chewing or crushing for 4 weeks.
Drug: DWP14012 40mg
DWP14012 40mg, tablet, orally, once daily for up to 4 weeks
Placebo Comparator: Placebo
Once daily with water regardless of meals without chewing or crushing for 4 weeks.
Drug: Placebo
Placebo, tablet, orally, once daily for up to 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of heartburn-free days for 4 weeks (daytime/nighttime)
Time Frame: 4 Weeks
4 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of major symptom-free (heartburn, acid regurgitation, or heartburn/acid regurgitation) days for 2 and 4 weeks (daytime/nighttime, daytime and nighttime)
Time Frame: 4 Weeks
4 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 16, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2023

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DW_DWP14012311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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