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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
149
Catholic yeouido sungmo hospital
Seoul, Seoul, South Korea
DongA university hospital
Busan, South Korea
Kyungbook University hospital
Daegu, South Korea
Chungnam university hospital
Daejeon, South Korea
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.
Time frame: 4 week
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.
Time frame: 4 week
the rate of subject who had 'complete recovery' after 1 week, 2 week, 3 week IP administraion
Time frame: 3 week
the rate of subject who had 'appropriate recovery' after 1 week, 2 week, 3 week IP administraion
Time frame: 3 week
the number of night symptom-free day after IP administration
Symptoms means "Heartburn or Acid regurgitation"
Time frame: 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
Time frame: 1 week, 2 week, 3 week, 4 week
Evalution of Clinical Global Impression of Change
Time frame: 4 week
Evaluation of Patient Global Impression of Change
Time frame: 4 week
the change of SF-36 Survey score between baseline and completion visit
Time frame: 4 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Catholic Incheon hospital
Incheon, South Korea
Jeonbuk University hospital
Jeonju, South Korea
Asan hospital
Seoul, South Korea
Konkuk unversity hospital
Seoul, South Korea
Kyunghee university hospital
Seoul, South Korea
Seoul university hospital
Seoul, South Korea
the change of ESS survey score among baseline, 2 week and 4 week
ESS stands for Epworth sleepiness scale.
Time frame: 2, 4 week
Safety
AE, Physical exam, 12-lead ECG, Vital signs, laboratory test
Time frame: 4 week