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

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Unknown status

CT.gov ID

NCT04325620

Collaborator

(none)

212

Enrollment

Location

Arms

Anticipated Duration (Months)

10.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Non-erosive Gastroesphageal Reflux Disease	Drug: HIP1601 Drug: HGP1805	Phase 3

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

Anticipated Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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)

Actual Study Start Date :

Apr 16, 2019

Anticipated Primary Completion Date :

Jul 16, 2020

Anticipated Study Completion Date :

Dec 16, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Percentage of patients with complete resolution of major symptoms at 4-week [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 [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) [2, 4 week]
RDQ frequncy and severity score is 0 to 5 point scale, high score mean a worse outcome.
Time to complete resolution of major symptoms [4 week]
defined as time to the first day of complete resolution
Resolution rate of major symptoms of first 7 days [1 week]
defined as first of 7 days with no episodes of symptom using subject's diary
Major symptoms-Free days [1, 4 week]
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) [4 week]
PAGI-QoL total score is 0 to 30 point scale, high score mean a better outcome.
Proportion of rescue medication amounts [4 week]
Use of rescue medication

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do	Korea, Republic of	13620

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT04325620

Other Study ID Numbers:

HM-ESOM-302

First Posted:

Mar 27, 2020

Last Update Posted:

Apr 15, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Gastroesophageal Reflux

Study Results

No Results Posted as of Apr 15, 2020