Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non-Erosive Gastroesophageal Reflux Disease (NERD)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
|
Outcome Measures
Primary Outcome Measures
- Percentage of heartburn-free days for 4 weeks (daytime/nighttime) [4 Weeks]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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
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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
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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
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
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Subjects who are diagnosed with erosive GERD, acute upper gastrointestinal bleeding, gastric ulcer, or duodenal ulcer within 8 weeks prior to Visit 1
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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
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Subjects who have history of alcohol or other drug abuse within 1 year prior to Visit 1
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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.)
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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
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Subjects who have or had bipolar disorder, anxiety disorder, panic disorder, somatoform disorder, personality disorder, or other clinically significant psychiatric disorders
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Subjects with scleroderma (systemic sclerosis) or systemic lupus erythematosus
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Wonkwang University Hospital | Iksan | Jeollabuk-do | Korea, Republic of | 54538 |
Sponsors and Collaborators
- Daewoong Pharmaceutical Co. LTD.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DW_DWP14012311