Phase 2 Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH1885L in Patients With Non-erosive Reflux Disease
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0000705
- Lead Sponsor
- Yuhan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 150
subjects who signed written informed consent form
- more than 20 yr subject
- subjects who agree the use of medically accepted birth control during trial
- grade N, M by EGD test
- subject who experience 2 day out of 1 week during recent 1 month
- subject who experience 2 day out of 1 week during run-in period
- Subjects who can write the diary by himself, herself
- Pregnant woman, breastfeeding woman
- Allgeric or intolerabiliy to revaprazan or esomeprazole
- Feeling of heavy stomach, distention
- Surgery history in stomach or esophagus
- Active medical history of stomach, esophagus area
- other system disorder which can disturb this trial
- Hep B, C virus, HIV carrier or patients
- Past history of malignant tumor
- Any psychiatric past or current history
- Abnormal lab test
- Abnormal ecg test
- Zollinger-ellison disease
- Current or past history of substance, drug abuse
- Subject who should regulary takes medication which can disturb this trial
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of subject who had 'complete recovery' of symptom after 4 week administration .
- Secondary Outcome Measures
Name Time Method The rate of subject who had 'appropriate recovery' of symptom after 4 week administration;The rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion ;The rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion;The number of night symptom-free day after IP administration ;The rate of subjects who have reduced average symptom score(more than 1) comparing to baseline score ;Evalution of Clinical Global Impression of Change ;Evaluation of Patient Global Impression of Change;The change of SF-36 Survey score between baseline and completion visit ;The change of ESS survey score among baseline, 2 week and 4 week