Status:
UNKNOWN
Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Non-Erosive Gastroesophageal Reflux Disease (NERD)
Lead Sponsor:
Daewoong Pharmaceutical Co. LTD.
Conditions:
Non-erosive Reflux Disease
Non-Erosive Gastro-Esophageal Reflux Disease
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- Subjects with hereditary disorders including galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
Key Trial Info
Start Date :
August 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2025
Estimated Enrollment :
324 Patients enrolled
Trial Details
Trial ID
NCT06121830
Start Date
August 31 2023
End Date
March 1 2025
Last Update
November 8 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Wonkwang University Hospital
Iksan, Jeollabuk-do, South Korea, 54538