Non-erosive Reflux Disease
Conditions
Brief summary
The purpose of this study is to demonstrate the superiority of efficacy of CJ-12420, once daily (QD), compared to placebo in patients with non-erosive reflux disease at Week 4
Detailed description
This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg or 100 mg or placebo). All subjects will be asked to take two tablets at the same time each day throughout the study, and also all subjects will be asked to record daily symptom in a subject diary on a daily basis.
Interventions
DRUGCJ-12420 50mg
CJ-12420 50mg, tablet, once daily, oral administration for up to 4 weeks
DRUGCJ-12420 100mg
CJ-12420 100mg, tablet, once daily, oral administration for up to 4 weeks
DRUGPlacebo
Placebo, tablet, once daily, oral administration for up to 4 weeks
Sponsors
HK inno.N Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects aged between 20 and 75 years 2. Subjects who had experienced a minimum three-month history of main symptom(heartburn and regurgitation) 3. Subjects were to have normal esophagus confirmed by endoscopy within 14 days prior to randomization 4. Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study 5. Subjects who voluntarily signed written informed consent form 6. Subjects who agreed to use medically acceptable contraceptives during the period of study 7. Subjects who had experienced heartburn and regurgitation within 7 days before randomization. Entry into study also required that patients had experienced at least mild upper gastrointestinal symptoms on at least 2 days/week or at least moderate upper gastrointestinal symptoms on at least 1 day/week
Exclusion criteria
1. Subjects who cannot undergo EGD 2. Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD 3. Subjects who have erosive esophagitis, acute upper gastrointestinal bleeding, gastric ulcers or duodenal ulcers, acute erosive gastritis within 2 months before randomization. Subjects with gastric or duodenal erosions are allowed to be included. 4. Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool 5. Subjects with eosinophilic esophagitis 6. Subjects diagnosed with functional dyspepsia, primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months 7. Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery 8. Subjects who have bipolar disorder, anxiety disorder, panic disorder, somatoform disorder, personality disorder and psychiatric disorders. 9. Subjects who are taking antipsychotic drugs, antidepressants or antianxiety medications 10. Subjects who should continuously administer NSAIDs during the trial. 11. Pregnant or lactating women 12. Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder 13. Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc. 14. Subjects who participated in the other clinical trial within 4 weeks prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with complete resolution of main symptoms (heartburn and regurgitation) at 4-week, defined as no episodes of symptom during the last 7 days of treatment, using Reflux Disease Questionnaire(RDQ) | 4 week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resolution of main symptoms(heartburn and regurgitation) at 2-week(for 7 consecutive days) | 2 week | — |
| RDQ score change | 4 week | — |
| Percentage of symptom free days | 4 week | Symptom will be collected by patient diary. |
Countries
South Korea
Outcome results
None listed