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Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04282954
Recruitment Status : Recruiting
First Posted : February 25, 2020
Last Update Posted : February 25, 2020
Sponsor:
Information provided by (Responsible Party):
Jeil Pharmaceutical Co., Ltd.

Brief Summary:
Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease

Condition or disease Intervention/treatment Phase
GERD Drug: JP-1366 Drug: JP-1366 placebo Drug: Esomeprazole 40mg Drug: Esomeprazole placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Active-controlled, Multi-center Phase II Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arm Intervention/treatment
Experimental: Group 1
JP-1366 A mg
Drug: JP-1366
JP-1366, QD

Drug: JP-1366 placebo
JP-1366 placebo, QD

Drug: Esomeprazole placebo
Esomeprazole placebo, QD

Experimental: Group 2
JP-1366 B mg
Drug: JP-1366
JP-1366, QD

Drug: JP-1366 placebo
JP-1366 placebo, QD

Drug: Esomeprazole placebo
Esomeprazole placebo, QD

Experimental: Group 3
JP-1366 C mg
Drug: JP-1366
JP-1366, QD

Drug: JP-1366 placebo
JP-1366 placebo, QD

Drug: Esomeprazole placebo
Esomeprazole placebo, QD

Active Comparator: Goup 4
Esomeprazole 40 mg
Drug: JP-1366 placebo
JP-1366 placebo, QD

Drug: Esomeprazole 40mg
Esomeprazole 40mg, QD




Primary Outcome Measures :
  1. Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%) [ Time Frame: 8 weeks ]
    * Erosion recovered to normal mucous membrane on upper gastrointestinal endoscopy



Information from the National Library of Medicine

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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:

  • Adults between 19 and 75 years old based on the date of written agreement
  • Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
  • Those who experienced symptoms of heartburn or acid reflux within the last 7 days

Exclusion Criteria:

  • Those who have undergone gastric acid suppression or gastric, esophageal surgery
  • Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
  • Clinically significant abnormal laboratory values during screening

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): NCT04282954


Locations
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Korea, Republic of
Severance Hospital and 19 hospitals Recruiting
Seoul, Korea, Republic of
Contact: YongChan Lee, M.D., Ph.D    82-2-2228-1960    leeyc@yuhs.ac   
Sponsors and Collaborators
Jeil Pharmaceutical Co., Ltd.
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Responsible Party: Jeil Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04282954    
Other Study ID Numbers: JP-1366-201
First Posted: February 25, 2020    Key Record Dates
Last Update Posted: February 25, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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