Efficacy and Safety of HIP1601 Capsule

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

The purpose of this study is to investigate the safety and clinical efficacy of HIP1601 in patients with erosive gastroesphageal reflux disease.

Study Overview

• Status: Completed
• Conditions: Erosive Gastroesophageal Reflux Disease
• Intervention / Treatment: Drug: HIP1601; Drug: HGP1705 Placebo; Drug: HGP1705; Drug: HIP1601 Placebo

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Asan Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HIP1601+HGP1705 Placebo; HIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks	Drug: HIP1601; Oral esomeprazole; Other Names: esomeprazole; Drug: HGP1705 Placebo; Oral Placebo
Experimental: HGP1705+HIP1601 Placebo; HGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks	Drug: HGP1705; Oral Nexium Tab; Other Names: Nexium Tab; Drug: HIP1601 Placebo; Oral Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete healing rate	percentage of subjects whose erosion is completely cured	at 4 weeks or 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete healing rate	percentage of subjects whose erosion is completely cured	at 4 weeks
Complete resolution rate of each symptom in GERD		at 4,8 weeks
Proportion of heartburn-free days, acid regurgitation-free days		at 1, 2, 4, 8 weeks
Proportion of heartburn-free nights, acid regurgitation-free nights		at 1, 2, 4, 8 weeks
Time to sustained resolution heartburn, acid regurgitation		at 4 weeks or 8 weeks
Time to sustained resolution of nocturnal heartburn, nocturnal acid regurgitation		at 4 weeks or 8 weeks
Total number of use of relief drugs and average usage per day		at 4 weeks or 8 weeks

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Hunyong Jung, MD, Ph.D., Asan Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2018
• Primary Completion (Actual): December 3, 2019
• Study Completion (Actual): December 3, 2019

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 4, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): November 30, 2020
• Last Update Submitted That Met QC Criteria: November 26, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Esomeprazole
• Other Study ID Numbers: HM-ESOM-301

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No