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

Primary Purpose

Non-erosive Gastroesphageal Reflux Disease

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HIP1601
HGP1805
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-erosive Gastroesphageal Reflux Disease

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Seoul National University Bundang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HIP1601 Amg

HGP1805

Arm Description

The participants will receive tretment of HIP1601 Amg, orally, once daily for 4weeks.

The participants will receive tretment of HGP1805(Placebo of HIP1601), orally, once daily for 4weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.
Time to complete resolution of major symptoms
defined as time to the first day of complete resolution
Resolution rate of major symptoms of first 7 days
defined as first of 7 days with no episodes of symptom using subject's diary
Major symptoms-Free days
Major symptoms-Free days mean rate of days that symtom's severity score is '0' using subject's diary
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.
Proportion of rescue medication amounts
Use of rescue medication

Full Information

First Posted
March 26, 2020
Last Updated
November 7, 2022
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04325620
Brief Title
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
August 3, 2020 (Actual)
Study Completion Date
August 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-erosive Gastroesphageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
208 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIP1601 Amg
Arm Type
Experimental
Arm Description
The participants will receive tretment of HIP1601 Amg, orally, once daily for 4weeks.
Arm Title
HGP1805
Arm Type
Placebo Comparator
Arm Description
The participants will receive tretment of HGP1805(Placebo of HIP1601), orally, once daily for 4weeks.
Intervention Type
Drug
Intervention Name(s)
HIP1601
Intervention Description
HIP1601
Intervention Type
Drug
Intervention Name(s)
HGP1805
Intervention Description
Placebo of HIP1601
Primary Outcome Measure Information:
Title
Percentage of patients with complete resolution of major symptoms at 4-week
Description
Complete resolution is defined as no episodes of symptom during the last 7 days of treatment.
Time Frame
4 week
Secondary Outcome Measure Information:
Title
Percentage of patients with complete resolution of major symptoms at 2-week
Description
Complete resolution is defined as no episodes of symptom during the last 7 days of treatment
Time Frame
2 week
Title
Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ)
Description
RDQ frequncy and severity score is 0 to 5 point scale, high score mean a worse outcome.
Time Frame
2, 4 week
Title
Time to complete resolution of major symptoms
Description
defined as time to the first day of complete resolution
Time Frame
4 week
Title
Resolution rate of major symptoms of first 7 days
Description
defined as first of 7 days with no episodes of symptom using subject's diary
Time Frame
1 week
Title
Major symptoms-Free days
Description
Major symptoms-Free days mean rate of days that symtom's severity score is '0' using subject's diary
Time Frame
1, 4 week
Title
Quality of Life assessment using Patient Assessment of upper Gastrointestinal disorders-Quality of Life(PAGI-QoL)
Description
PAGI-QoL total score is 0 to 30 point scale, high score mean a better outcome.
Time Frame
4 week
Title
Proportion of rescue medication amounts
Description
Use of rescue medication
Time Frame
4 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
State/Province
Gyeonggi-do
ZIP/Postal Code
13620
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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

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