NCT04325620CompletedPhase 3
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)
Hanmi Pharmaceutical Company Limited1 site in 1 country208 target enrollmentStarted: June 10, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 208
- Locations
- 1
- Primary Endpoint
- Percentage of patients with complete resolution of major symptoms at 4-week
Study Overview
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 19 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
HIP1601 Amg
Experimental
The participants will receive tretment of HIP1601 Amg, orally, once daily for 4weeks.
Intervention: HIP1601 (Drug)
HGP1805
Placebo Comparator
The participants will receive tretment of HGP1805(Placebo of HIP1601), orally, once daily for 4weeks.
Intervention: HGP1805 (Drug)
Outcomes
Primary Outcomes
Percentage of patients with complete resolution of major symptoms at 4-week
Time Frame: 4 week
Complete resolution is defined as no episodes of symptom during the last 7 days of treatment.
Secondary Outcomes
- Major symptoms-Free days(1, 4 week)
- Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ)(2, 4 week)
- Percentage of patients with complete resolution of major symptoms at 2-week(2 week)
- Time to complete resolution of major symptoms(4 week)
- Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL)(4 week)
- Resolution rate of major symptoms of first 7 days(1 week)
- Proportion of rescue medication amounts(4 week)
Investigators
Study Sites (1)
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