Efficacy and Safety of HIP1601 Capsule

• Status: Completed
• Trial end date: 2019-12-03
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with erosive gastroesphageal reflux disease.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited
• Treatments: Esomeprazole

Criteria

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)