Clinical trial NCT04325620: Safety to Evaluate the Efficacy and Safety of HIP1601 in Patients With Non Erosive Reflux Disease
Official title: A Multicenter, Randomized, Parallel, Double-Blinded, Placebo-controlled Phase 3 Study to Compare Efficacy and Safety of HIP1601 in Patients With Non-Erosive Gastroesophageal Reflux Disease(NERD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-erosive Gastroesphageal Reflux Disease
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2020-03-27
Enrollment: 208
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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)

Primary outcomes:
measure: Percentage of patients with complete resolution of major symptoms at 4-week
timeFrame: 4 week
Secondary outcomes:
measure: Percentage of patients with complete resolution of major symptoms at 2-week
timeFrame: 2 week
measure: Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ)
timeFrame: 2, 4 week
measure: Time to complete resolution of major symptoms
timeFrame: 4 week
measure: Resolution rate of major symptoms of first 7 days
timeFrame: 1 week
measure: Major symptoms-Free days
timeFrame: 1, 4 week
measure: Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL)
timeFrame: 4 week
measure: Proportion of rescue medication amounts
timeFrame: 4 week
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
References: