Efficacy and Safety of HIP1601 Capsule
Phase 3
Completed
- Conditions
- Erosive Gastroesophageal Reflux Disease
- Interventions
- Registration Number
- NCT04080726
- Lead Sponsor
- Hanmi Pharmaceutical Company Limited
- Brief Summary
The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with erosive gastroesphageal reflux disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 213
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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HIP1601+HGP1705 Placebo HGP1705 Placebo HIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks HGP1705+HIP1601 Placebo HGP1705 HGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks HGP1705+HIP1601 Placebo HIP1601 Placebo HGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks HIP1601+HGP1705 Placebo HIP1601 HIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks
- Primary Outcome Measures
Name Time Method Complete healing rate at 4 weeks or 8 weeks percentage of subjects whose erosion is completely cured
- Secondary Outcome Measures
Name Time Method Complete healing rate at 4 weeks percentage of subjects whose erosion is completely cured
Time to sustained resolution heartburn, acid regurgitation at 4 weeks or 8 weeks 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 Total number of use of relief drugs and average usage per day at 4 weeks or 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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie HIP1601's efficacy in erosive gastroesophageal reflux disease?
How does HIP1601 compare to HGP1705 in healing esophageal erosions and symptom resolution?
Which biomarkers correlate with response to HIP1601 in patients with erosive GERD?
What are the safety profiles of HIP1601 and HGP1705 in phase 3 GERD trials?
How do PPIs like HIP1601 compare to other acid suppression therapies for erosive GERD?
Trial Locations
- Locations (1)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Asan Medical Center🇰🇷Seoul, Korea, Republic of