Efficacy and Safety of HIP1601 Capsule

Erosive Gastroesophageal Reflux Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04080726
• Other study ID #: HM-ESOM-301
• Status: Completed
• Phase: Phase 3
• Start date: October 25, 2018
• Est. completion date: December 3, 2019

Study information

• Verified date: November 2020
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 213
• Est. completion date: December 3, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Erosive Gastroesophageal Reflux Disease
• Gastroesophageal Reflux

Intervention

Drug:
• HIP1601
Oral esomeprazole
• HGP1705
Oral Nexium Tab
• HIP1601 Placebo
Oral Placebo
• HGP1705 Placebo
Oral Placebo

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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