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Efficacy and Safety of HIP1601 Capsule

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04080726
Recruitment Status : Completed
First Posted : September 6, 2019
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

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

Condition or disease Intervention/treatment Phase
Erosive Gastroesophageal Reflux Disease Drug: HIP1601 Drug: HGP1705 Drug: HIP1601 Placebo Drug: HGP1705 Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 213 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: multicenter, randomized, double-blind, parallel group study
Masking: Double (Participant, Investigator)
Masking Description: double-blind
Primary Purpose: Treatment
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
Actual Study Start Date : October 25, 2018
Actual Primary Completion Date : December 3, 2019
Actual Study Completion Date : December 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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Arm Intervention/treatment
Experimental: HIP1601+HGP1705 Placebo
HIP1601+HGP1705 Placebo for 4weeks. if not fully cured, take HIP1601+HGP1705 Placebo for addtional 4weeks
 Drug: HIP1601
Oral esomeprazole
Other Name: esomeprazole

Drug: HGP1705 Placebo
Oral Placebo
Experimental: HGP1705+HIP1601 Placebo
HGP1705+HIP1601 Placebo for 4weeks. if not fully cured, take HGP1705+HIP1601 Placebo for addtional 4weeks
 Drug: HGP1705
Oral Nexium Tab
Other Name: Nexium Tab

Drug: HIP1601 Placebo
Oral Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Complete healing rate [ Time Frame: at 4 weeks or 8 weeks ]
    percentage of subjects whose erosion is completely cured


Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04080726


Locations
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Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Principal Investigator: Hunyong Jung, MD, Ph.D. Asan Medical Center
More Information
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT04080726    
Other Study ID Numbers: HM-ESOM-301
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
 Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action