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

NCT04325620 | Completed Phase 3

• 1 other identifier: HM-ESOM-302
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-erosive Gastroesphageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Percentage of patients with complete resolution of major symptoms at 2-week

  2 week

• Frequency and Severity of Reflux disease symptom assessment using Reflux Disease Questionnaire(RDQ)

  2, 4 week

• Time to complete resolution of major symptoms

  4 week

• Resolution rate of major symptoms of first 7 days

  1 week

• Major symptoms-Free days

  1, 4 week

Study Arms (2)

HIP1601 Amg

EXPERIMENTAL

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

Drug: HIP1601

HGP1805

PLACEBO COMPARATOR

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

Drug: HGP1805

Interventions

HIP1601 DRUG

HIP1601

HIP1601 Amg

HGP1805 DRUG

Placebo of HIP1601

HGP1805

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≤ 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2020
• First Posted: March 27, 2020
• Study Start: June 10, 2019
• Primary Completion: August 3, 2020
• Study Completion: August 3, 2020
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)