Phase 2 Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH1885L in Patients With Non-erosive Reflux Disease(NERD)

Study Overview
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Brief Summary
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Randomized, double-blind, active-controlled, multi-center phase 2 clinical trial to investigate the safety, tolerability and efficacy of YH1885L in patients with non-erosive reflux disease(NERD)

Official Title
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Randomized, Double-blind, Active-controlled, Multi-center Phase 2 Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH1885L in Patients With Non-erosive Reflux Disease(NERD)

Conditions
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Non-erosive Reflux Disease

Intervention / Treatment
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* Drug: YH1885L(Revaprazan)
* Drug: Esomeprazole 20mg
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YH1885L 33.3 mg<br>TID, Subject takes it for 4 week. | Drug: YH1885L(Revaprazan)<br> <br> |
| Experimental: YH1885L 50mg<br>BID, Subject takes it for 4 week. | Drug: YH1885L(Revaprazan)<br> <br> Drug: placebo<br> <br> |
| Experimental: YH1885L 66.6 mg<br>TID, Subject takes it for 4 week. | Drug: YH1885L(Revaprazan)<br> <br> |
| Experimental: YH1885L 100mg<br>BID, Subject takes it for 4 week. | Drug: YH1885L(Revaprazan)<br> <br> Drug: placebo<br> <br> |
| Active Comparator: Esomeprazole 20mg<br>QD, Subject takes it for 4 week. | Drug: Esomeprazole 20mg<br> <br> * Other names: Nexium;Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of subject who had 'complete recovery' of symptom after 4 week administration | 'complete recovery' means subjects never experience heartburn or acid regurgitation during last 1 week. | 4 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the rate of subject who had 'appropriate recovery' of symptom after 4 week administration | 'Appropriate recovery' means subjects experience heartburn or acid regurgitation only 1 or less during last 1 week. | 4 week | 
| the rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion |  | 3 week | 
| the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion |  | 3 week | 
| the number of night symptom-free day after IP administration | Symptoms means Heartburn or Acid regurgitation | 1 week, 2 week, 3 week, 4 week | 
| the rate of subjects who have reduced average symptom score(more than 1) comparing to baseline score |  | 1 week, 2 week, 3 week, 4 week | 
| Evalution of Clinical Global Impression of Change |  | 4 week | 
| Evaluation of Patient Global Impression of Change |  | 4 week | 
| the change of SF-36 Survey score between baseline and completion visit |  | 4 week | 
| the change of ESS survey score among baseline, 2 week and 4 week | ESS stands for Epworth sleepiness scale. | 2, 4 week | 
| Safety | AE, Physical exam, 12-lead ECG, Vital signs, laboratory test | 4 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NERD