The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.
A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 in Patients with Non-Erosive Gastroesophageal Reflux Disease(NERD)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
208
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Percentage of patients with complete resolution of major symptoms at 4-week
Complete resolution is defined as no episodes of symptom during the last 7 days of treatment.
Time frame: 4 week
Percentage of patients with complete resolution of major symptoms at 2-week
Complete resolution is defined as no episodes of symptom during the last 7 days of treatment
Time frame: 2 week
Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ)
RDQ frequncy and severity score is 0 to 5 point scale, high score mean a worse outcome.
Time frame: 2, 4 week
Time to complete resolution of major symptoms
defined as time to the first day of complete resolution
Time frame: 4 week
Resolution rate of major symptoms of first 7 days
defined as first of 7 days with no episodes of symptom using subject's diary
Time frame: 1 week
Major symptoms-Free days
Major symptoms-Free days mean rate of days that symtom's severity score is '0' using subject's diary
Time frame: 1, 4 week
Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL)
PAGI-QoL total score is 0 to 30 point scale, high score mean a better outcome.
Time frame: 4 week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Proportion of rescue medication amounts
Use of rescue medication
Time frame: 4 week