Safety to Evaluate the Efficacy and Safety of HIP1601 in Patients With Non Erosive Reflux Disease (NCT04325620) | Clinical Trial Compass
CompletedPhase 3
Safety to Evaluate the Efficacy and Safety of HIP1601 in Patients With Non Erosive Reflux Disease
South Korea208 participantsStarted 2019-06-10
Plain-language summary
The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.
Who can participate
Age range19 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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(MD…
What they're measuring
1
Percentage of patients with complete resolution of major symptoms at 4-week