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

NCT06121830 | Unknown Phase 3

• 1 other identifier: DW_DWP14012311
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Non-erosive Reflux Disease; Non-Erosive Gastro-Esophageal Reflux Disease; Non-Erosive Esophageal Reflux Disease

Keywords

NERD

Outcome Measures

Primary Outcomes (1)

• Percentage of heartburn-free days for 4 weeks (daytime/nighttime)

  4 Weeks

Secondary Outcomes (1)

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

  4 Weeks

Study Arms (3)

DWP14012 20mg

EXPERIMENTAL

Once daily with water regardless of meals without chewing or crushing for 4 weeks.

Drug: DWP14012 20mg

DWP14012 40mg

EXPERIMENTAL

Once daily with water regardless of meals without chewing or crushing for 4 weeks.

Drug: DWP14012 40mg

Placebo

PLACEBO COMPARATOR

Once daily with water regardless of meals without chewing or crushing for 4 weeks.

Drug: Placebo

Interventions

DWP14012 20mg DRUG

DWP14012 20mg, tablet, orally, once daily for up to 4 weeks

DWP14012 20mg

DWP14012 40mg DRUG

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

DWP14012 40mg

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Wonkwang University Hospital

Iksan, Jeollabuk-do, 54538, South Korea

RECRUITING

MeSH Terms

Conditions

Non-Erosive Reflux Disease

Interventions

fexuprazan

Condition Hierarchy (Ancestors)

Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2023
• First Posted: November 8, 2023
• Study Start: August 31, 2023
• Primary Completion: January 1, 2025
• Study Completion: March 1, 2025
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)