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OpenTrials
Completed

NCT Number: NCT04080726

Efficacy and Safety of HIP1601 Capsule

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

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Key information

Age range

19 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Asan Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

HIP1601

Drug

Oral esomeprazole

Other names: esomeprazole

HGP1705

Drug

Oral Nexium Tab

Other names: Nexium Tab

HIP1601 Placebo

Drug

Oral Placebo

HGP1705 Placebo

Drug

Oral Placebo

Primary outcomes

  1. Complete healing rate

    Time frame: at 4 weeks or 8 weeks

    percentage of subjects whose erosion is completely cured

Secondary outcomes

  1. Complete healing rate

    Time frame: at 4 weeks

    percentage of subjects whose erosion is completely cured

  2. Complete resolution rate of each symptom in GERD

    Time frame: at 4,8 weeks

  3. Proportion of heartburn-free days, acid regurgitation-free days

    Time frame: at 1, 2, 4, 8 weeks

  4. Proportion of heartburn-free nights, acid regurgitation-free nights

    Time frame: at 1, 2, 4, 8 weeks

  5. Time to sustained resolution heartburn, acid regurgitation

    Time frame: at 4 weeks or 8 weeks

  6. Time to sustained resolution of nocturnal heartburn, nocturnal acid regurgitation

    Time frame: at 4 weeks or 8 weeks

  7. Total number of use of relief drugs and average usage per day

    Time frame: at 4 weeks or 8 weeks

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Sep 6, 2019
Registry last updated
Nov 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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