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

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)

The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with Non-erosive gastroesphageal reflux disease.

Study Overview

• Status: Completed
• Conditions: Non-erosive Gastroesphageal Reflux Disease
• Intervention / Treatment: Drug: HIP1601; Drug: HGP1805

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 Type: Interventional
• Enrollment (Actual): 208
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIP1601 Amg; The participants will receive tretment of HIP1601 Amg, orally, once daily for 4weeks.	Drug: HIP1601; HIP1601
Placebo Comparator: HGP1805; The participants will receive tretment of HGP1805(Placebo of HIP1601), orally, once daily for 4weeks.	Drug: HGP1805; Placebo of HIP1601

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with complete resolution of major symptoms at 4-week	Complete resolution is defined as no episodes of symptom during the last 7 days of treatment.	4 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of patients with complete resolution of major symptoms at 2-week	Complete resolution is defined as no episodes of symptom during the last 7 days of treatment	2 week
Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ)	RDQ frequncy and severity score is 0 to 5 point scale, high score mean a worse outcome.	2, 4 week
Time to complete resolution of major symptoms	defined as time to the first day of complete resolution	4 week
Resolution rate of major symptoms of first 7 days	defined as first of 7 days with no episodes of symptom using subject's diary	1 week
Major symptoms-Free days	Major symptoms-Free days mean rate of days that symtom's severity score is '0' using subject's diary	1, 4 week
Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL)	PAGI-QoL total score is 0 to 30 point scale, high score mean a better outcome.	4 week
Proportion of rescue medication amounts	Use of rescue medication	4 week

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2019
• Primary Completion (Actual): August 3, 2020
• Study Completion (Actual): August 3, 2020

Study Registration Dates

• First Submitted: March 26, 2020
• First Submitted That Met QC Criteria: March 26, 2020
• First Posted (Actual): March 27, 2020

Study Record Updates

• Last Update Posted (Actual): November 9, 2022
• Last Update Submitted That Met QC Criteria: November 7, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux
• Other Study ID Numbers: HM-ESOM-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No