Status:
COMPLETED
Efficacy and Safety of HIP1601 Capsule
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Erosive Gastroesophageal Reflux Disease
Eligibility:
All Genders
19-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with erosive gastroesphageal reflux disease.
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
October 25 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 3 2019
Estimated Enrollment :
213 Patients enrolled
Trial Details
Trial ID
NCT04080726
Start Date
October 25 2018
End Date
December 3 2019
Last Update
November 30 2020
Active Locations (1)
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1
Asan Medical Center
Seoul, South Korea