Erosive Gastroesophageal Reflux Disease
Conditions
Brief summary
The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with erosive gastroesphageal reflux disease.
Interventions
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
double-blind
Intervention model description
multicenter, randomized, double-blind, parallel group study
Eligibility
Sex/Gender
ALL
Age
19 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 19≤ age ≤ 75 * Esophago-Gastro-Duodenoscopy LA classification ≥ grade A * Patients experienced heartburn or acid regurgitation within 7 days of screening day * Patients understood the consents and purpose of this trial and signed consent form
Exclusion criteria
* Has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorder or signs of gastrointestinal bleeding * Has a severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range) * Has a clinically significant renal failure(at screening day, MDRD eGFP ≤ 59 mL/min/1.73m2 or Serum creatinine \>2.0mg/dL) * Uncontrolled diabetes mellitus * Before screening EGD, a patient who has taken H2-receptor antagonist or PPI within 2 weeks * Before screening EGD, a patient who has taken drugs containing following list within 1 weeks : warfarin, anticholinergics for spasmolytic GI, antineoplastic agents, salicylates(except 100mg a day for prevention of cardiovascular disease), steroids, propulsives, sucralfate, NSAIDs, other antacids(e.g. antacids of prostaglandin analogs, antacids of aluminum/magnesium)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete healing rate | at 4 weeks or 8 weeks | percentage of subjects whose erosion is completely cured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete healing rate | at 4 weeks | percentage of subjects whose erosion is completely cured |
| Complete resolution rate of each symptom in GERD | at 4,8 weeks | — |
| Proportion of heartburn-free days, acid regurgitation-free days | at 1, 2, 4, 8 weeks | — |
| Proportion of heartburn-free nights, acid regurgitation-free nights | at 1, 2, 4, 8 weeks | — |
| Time to sustained resolution of nocturnal heartburn, nocturnal acid regurgitation | at 4 weeks or 8 weeks | — |
| Total number of use of relief drugs and average usage per day | at 4 weeks or 8 weeks | — |
| Time to sustained resolution heartburn, acid regurgitation | at 4 weeks or 8 weeks | — |
Countries
South Korea
Outcome results
None listed