Last updated: November 26, 2020
Sponsor: Hanmi Pharmaceutical Company Limited
Overall Status: Completed
Phase
3
Condition
Gastroesophageal Reflux Disease (Gerd)
Heartburn (Pediatric)
Esophageal Disorders
Treatment
N/AClinical Study ID
NCT04080726
HM-ESOM-301
Ages 19-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
Exclusion Criteria:
- Has malignancy in the upper gastrointestinal tract, digestive ulcer, bleeding disorderor signs of gastrointestinal bleeding
- Has a severe liver disorder(at screening day, AST or ALT level exceeds 3 times morethan normal upper range)
- Has a clinically significant renal failure(at screening day, MDRD eGFP ≤ 59mL/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 2weeks
- Before screening EGD, a patient who has taken drugs containing following list within 1weeks : 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 prostaglandinanalogs, antacids of aluminum/magnesium)
Study Design
Total Participants: 213
Study Start date:
October 25, 2018
Estimated Completion Date:
December 03, 2019
Connect with a study center
Asan Medical Center
Seoul,
Korea, Republic ofSite Not Available
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