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

NCT ID: NCT04325620

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-10
• Study Completion Date: 2020-08-03

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)

Conditions

Non-erosive Gastroesphageal Reflux Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

HIP1601 Amg

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

Group Type: EXPERIMENTAL

HIP1601

Intervention Type: DRUG

HIP1601

HGP1805

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

Group Type: PLACEBO_COMPARATOR

HGP1805

Intervention Type: DRUG

Placebo of HIP1601

Interventions

HIP1601

HIP1601

Intervention Type: DRUG

HGP1805

Placebo of HIP1601

Intervention Type: DRUG

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)

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hanmi Pharmaceutical Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

HM-ESOM-302

Identifier Type: -

Identifier Source: org_study_id