Overview

Safety to Evaluate the Efficacy and Safety of HIP1601 in Patients With Non Erosive Reflux Disease

Status:
Recruiting
Trial end date:
2020-12-16
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 Non-erosive gastroesphageal reflux disease.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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)