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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DWP14012 20mg | Experimental | Once daily with water regardless of meals without chewing or crushing for 4 weeks. |
|
| DWP14012 40mg | Experimental | Once daily with water regardless of meals without chewing or crushing for 4 weeks. |
|
| Placebo | Placebo Comparator | Once daily with water regardless of meals without chewing or crushing for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DWP14012 20mg | Drug | DWP14012 20mg, tablet, orally, once daily for up to 4 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of heartburn-free days for 4 weeks (daytime/nighttime) | 4 Weeks |
| Measure | Description | 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) | 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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 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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonkwang University Hospital | Recruiting | Iksan | Jeollabuk-do | 54538 | South Korea |
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| DWP14012 40mg |
| Drug |
DWP14012 40mg, tablet, orally, once daily for up to 4 weeks |
|
| Placebo | Drug | Placebo, tablet, orally, once daily for up to 4 weeks |
|
| ID | Term |
|---|---|
| D000096663 | Non-Erosive Reflux Disease |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000634065 | fexuprazan |
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