Non-erosive Gastroesphageal Reflux Disease
Conditions
Brief summary
The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.
Detailed description
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)
Interventions
DRUGHIP1601
HIP1601
DRUGHGP1805
Placebo of HIP1601
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 19≤ age ≤ 75 * Patients who were not observed mucosal break('not present') according to the LA classification(LA grade) on the EGDEsophago-Gastro-Duodenoscopy * Patients who had experienced major symptom within 3 months Patients experienced heartburn or acid regurgitation within 7 days of screening day * Patients who had experienced major symptom within 7 days before randomization. Entry into study also required that patients had experienced at least mild symptoms on at least 2 days/week or at least moderate symptoms on at least 1 day/week based on RDQ * Patients understood the consents and purpose of this trial and signed consent form
Exclusion criteria
* Patients who have erosive GERD, Barrett's esophagus(other significant dysplasia of esophagus), gastroesophageal varicose veins, active peptic ulcer, gastrointestinal bleeding or malignant GI tumor confirmed by endoscopy * Patients who have a history of gastric or gastroesophageal surgery * Patients who have Zollinger-Ellison syndrome, eosinophilic esophagitis, primary esophageal motility disorder, acute upper gastrointestinal bleeding, Functional dyspepsia, IBS, IBD within 3 months before Visit 1 * Patients with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease. * Patients Has a severe liver disorder(AST or ALT level exceeds 3 times more than normal upper range at Visit 1) * Has a clinically significant renal failure(MDRD eGFR ≤ 59 mL/min/1.73m2 or Serum creatinine \>2.0mg/dL at Visit 1)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with complete resolution of major symptoms at 4-week | 4 week | Complete resolution is defined as no episodes of symptom during the last 7 days of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ) | 2, 4 week | RDQ frequncy and severity score is 0 to 5 point scale, high score mean a worse outcome. |
| Time to complete resolution of major symptoms | 4 week | defined as time to the first day of complete resolution |
| Resolution rate of major symptoms of first 7 days | 1 week | defined as first of 7 days with no episodes of symptom using subject's diary |
| Percentage of patients with complete resolution of major symptoms at 2-week | 2 week | Complete resolution is defined as no episodes of symptom during the last 7 days of treatment |
| Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL) | 4 week | PAGI-QoL total score is 0 to 30 point scale, high score mean a better outcome. |
| Proportion of rescue medication amounts | 4 week | Use of rescue medication |
| Major symptoms-Free days | 1, 4 week | Major symptoms-Free days mean rate of days that symtom's severity score is '0' using subject's diary |
Countries
South Korea
Outcome results
None listed