Non-erosive Reflux Disease
Conditions
Keywords
NERD
Brief summary
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)
Interventions
Sponsors
Yuhan Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of subject who had 'complete recovery' of symptom after 4 week administration | 4 week | 'complete recovery' means subjects never experience heartburn or acid regurgitation during last 1 week. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the rate of subject who had 'appropriate recovery' of symptom after 4 week administration | 4 week | 'Appropriate recovery' means subjects experience heartburn or acid regurgitation only 1 or less during last 1 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 | 1 week, 2 week, 3 week, 4 week | Symptoms means Heartburn or Acid regurgitation |
| 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 | — |
| 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 | 2, 4 week | ESS stands for Epworth sleepiness scale. |
| Safety | 4 week | AE, Physical exam, 12-lead ECG, Vital signs, laboratory test |
| Evalution of Clinical Global Impression of Change | 4 week | — |
Other
| Measure | Time frame |
|---|---|
| Comparison of H.pylori(+),(-) subjects about primay and seconday outcome | 4 week |
Countries
South Korea
Outcome results
None listed