Status:
COMPLETED
Safety to Evaluate the Efficacy and Safety of HIP1601 in Patients With Non Erosive Reflux Disease
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Non-erosive Gastroesphageal 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 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)
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
June 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 3 2020
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT04325620
Start Date
June 10 2019
End Date
August 3 2020
Last Update
November 9 2022
Active Locations (1)
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1
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea, 13620