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Efficacy and Safety of HIP1601 Capsule

Primary Purpose

Erosive Gastroesophageal Reflux Disease

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
HIP1601
HGP1705
HIP1601 Placebo
HGP1705 Placebo
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erosive Gastroesophageal Reflux Disease

Eligibility Criteria

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

Inclusion Criteria:

  • 19≤ age ≤ 75
  • Esophago-Gastro-Duodenoscopy LA classification ≥ grade A
  • Patients experienced heartburn or acid regurgitation within 7 days of screening day
  • Patients understood the consents and purpose of this trial and signed consent form

Exclusion Criteria:

  • Has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorder or signs of gastrointestinal bleeding
  • Has a severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range)
  • Has a clinically significant renal failure(at screening day, MDRD eGFP ≤ 59 mL/min/1.73m2 or Serum creatinine >2.0mg/dL)
  • Uncontrolled diabetes mellitus
  • Before screening EGD, a patient who has taken H2-receptor antagonist or PPI within 2 weeks
  • Before screening EGD, a patient who has taken drugs containing following list within 1 weeks : warfarin, anticholinergics for spasmolytic GI, antineoplastic agents, salicylates(except 100mg a day for prevention of cardiovascular disease), steroids, propulsives, sucralfate, NSAIDs, other antacids(e.g. antacids of prostaglandin analogs, antacids of aluminum/magnesium)

Sites / Locations

  • Asan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

HIP1601+HGP1705 Placebo

HGP1705+HIP1601 Placebo

Arm Description

HIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks

HGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks

Outcomes

Primary Outcome Measures

Complete healing rate
percentage of subjects whose erosion is completely cured

Secondary Outcome Measures

Complete healing rate
percentage of subjects whose erosion is completely cured
Complete resolution rate of each symptom in GERD
Proportion of heartburn-free days, acid regurgitation-free days
Proportion of heartburn-free nights, acid regurgitation-free nights
Time to sustained resolution heartburn, acid regurgitation
Time to sustained resolution of nocturnal heartburn, nocturnal acid regurgitation
Total number of use of relief drugs and average usage per day

Full Information

First Posted
September 4, 2019
Last Updated
November 26, 2020
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04080726
Brief Title
Efficacy and Safety of HIP1601 Capsule
Official Title
A Multicenter, Randomized, Double-blind, Phase Ⅲ Study to Compare Efficacy and Safety of HIP1601 40mg and HGP1705 40mg in Patients With Erosive Gastroesophageal Reflux Disease
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
December 3, 2019 (Actual)
Study Completion Date
December 3, 2019 (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 erosive gastroesphageal reflux disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Gastroesophageal Reflux Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
multicenter, randomized, double-blind, parallel group study
Masking
ParticipantInvestigator
Masking Description
double-blind
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HIP1601+HGP1705 Placebo
Arm Type
Experimental
Arm Description
HIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks
Arm Title
HGP1705+HIP1601 Placebo
Arm Type
Experimental
Arm Description
HGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks
Intervention Type
Drug
Intervention Name(s)
HIP1601
Other Intervention Name(s)
esomeprazole
Intervention Description
Oral esomeprazole
Intervention Type
Drug
Intervention Name(s)
HGP1705
Other Intervention Name(s)
Nexium Tab
Intervention Description
Oral Nexium Tab
Intervention Type
Drug
Intervention Name(s)
HIP1601 Placebo
Intervention Description
Oral Placebo
Intervention Type
Drug
Intervention Name(s)
HGP1705 Placebo
Intervention Description
Oral Placebo
Primary Outcome Measure Information:
Title
Complete healing rate
Description
percentage of subjects whose erosion is completely cured
Time Frame
at 4 weeks or 8 weeks
Secondary Outcome Measure Information:
Title
Complete healing rate
Description
percentage of subjects whose erosion is completely cured
Time Frame
at 4 weeks
Title
Complete resolution rate of each symptom in GERD
Time Frame
at 4,8 weeks
Title
Proportion of heartburn-free days, acid regurgitation-free days
Time Frame
at 1, 2, 4, 8 weeks
Title
Proportion of heartburn-free nights, acid regurgitation-free nights
Time Frame
at 1, 2, 4, 8 weeks
Title
Time to sustained resolution heartburn, acid regurgitation
Time Frame
at 4 weeks or 8 weeks
Title
Time to sustained resolution of nocturnal heartburn, nocturnal acid regurgitation
Time Frame
at 4 weeks or 8 weeks
Title
Total number of use of relief drugs and average usage per day
Time Frame
at 4 weeks or 8 weeks

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 Esophago-Gastro-Duodenoscopy LA classification ≥ grade A Patients experienced heartburn or acid regurgitation within 7 days of screening day Patients understood the consents and purpose of this trial and signed consent form Exclusion Criteria: Has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorder or signs of gastrointestinal bleeding Has a severe liver disorder(at screening day, AST or ALT level exceeds 3 times more than normal upper range) Has a clinically significant renal failure(at screening day, MDRD eGFP ≤ 59 mL/min/1.73m2 or Serum creatinine >2.0mg/dL) Uncontrolled diabetes mellitus Before screening EGD, a patient who has taken H2-receptor antagonist or PPI within 2 weeks Before screening EGD, a patient who has taken drugs containing following list within 1 weeks : warfarin, anticholinergics for spasmolytic GI, antineoplastic agents, salicylates(except 100mg a day for prevention of cardiovascular disease), steroids, propulsives, sucralfate, NSAIDs, other antacids(e.g. antacids of prostaglandin analogs, antacids of aluminum/magnesium)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hunyong Jung, MD, Ph.D.
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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Efficacy and Safety of HIP1601 Capsule

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