Efficacy and Safety of HIP1601 Capsule

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/A

Clinical Study ID

NCT04080726
HM-ESOM-301
  • Ages 19-75
  • All Genders

Study Summary

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

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 of

    Site Not Available

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