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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04080726
Other study ID # HM-ESOM-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
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Completed NCT03184324 - Study to Evaluate the Efficacy and Safety of DWP14012 in Patients With Erosive Gastroesophageal Reflux Disease (Phase 2, Therapeutic Exploratory Study) Phase 2