GERD
Conditions
Brief summary
Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease
Interventions
DRUGJP-1366
JP-1366, QD
DRUGJP-1366 placebo
JP-1366 placebo, QD
DRUGEsomeprazole 40mg
Esomeprazole 40mg, QD
Esomeprazole placebo, QD
Sponsors
Onconic Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Adults between 19 and 75 years old based on the date of written agreement * Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy * Those who experienced symptoms of heartburn or acid reflux within the last 7 days
Exclusion criteria
* Those who have undergone gastric acid suppression or gastric, esophageal surgery * Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease * Clinically significant abnormal laboratory values during screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%) | 8 weeks | \* Erosion recovered to normal mucous membrane on upper gastrointestinal endoscopy |
Countries
South Korea
Outcome results
None listed