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Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis

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: NCT02456935
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
HK inno.N Corporation

Brief Summary:
The purpose of this study is to demonstrate the efficacy of CJ-12420, once daily (QD), compared to esomeprazole in patients with erosive esophagitis classified as Los Angeles (LA) classification grades A to D at Week 8

Condition or disease Intervention/treatment Phase
Erosive Esophagitis Drug: CJ-12420 100 mg QD Drug: Esomeprazole 40 mg QD Phase 3

Detailed Description:

This is a double blind, randomized, active controlled, phase 3 study. Subjects will be randomly assigned to one of the two treatment groups (CJ-12420 100 mg or esomeprazole 40 mg).

All subjects will be asked to take two tablets at the same time each day throughout the study, and also all subjects will be asked to record daytime and nighttime symptom in a subject diary on a daily basis.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Active-controlled, Phase 3 Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
Study Start Date : May 2015
Actual Primary Completion Date : July 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: CJ-12420 100 mg QD
CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks
Drug: CJ-12420 100 mg QD
CJ-12420 100 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 100 mg.
Other Name: Not yet decided

Active Comparator: Esomeprazole 40 mg QD
Esomeprazole 40 mg, tablet, once daily, oral administration for up to 8 weeks
Drug: Esomeprazole 40 mg QD
Esomeprazole 40 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of Esomeprazole 40 mg.
Other Name: Nexium




Primary Outcome Measures :
  1. Cumulative healing rate of erosive esophagitis at 8-week [ Time Frame: 8 week ]

Secondary Outcome Measures :
  1. Healing rate of erosive esophagitis at 4-week [ Time Frame: 4 week ]
  2. Symptom assessment by subject diary and questionnaire [ Time Frame: 4 week or 8 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects aged between 20 and 70 years
  2. Subjects who had experienced heartburn and regurgitation within 7 days before visit 1. Entry into study also required that patients had experienced at least mild upper gastrointestinal symptoms on at least 2 days/week or at least moderate upper gastrointestinal symptoms on at least 1 day/week
  3. Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization
  4. Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study
  5. Subjects who voluntarily signed written informed consent form
  6. Subjects who agreed to use medically acceptable contraceptives during the period of study.

Exclusion Criteria:

  1. Subjects who cannot undergo EGD
  2. Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD
  3. Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool
  4. Subjects with eosinophilic esophagitis
  5. Subjects diagnosed with primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months
  6. Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery
  7. Pregnant or lactating women
  8. Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder
  9. Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc.
  10. Subjects who participated in the other clinical trial within 4 weeks prior to randomization

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): NCT02456935


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
HK inno.N Corporation
Investigators
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Principal Investigator: Hyun Chae Jung, Ph.D Seoul National University Hospital
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Responsible Party: HK inno.N Corporation
ClinicalTrials.gov Identifier: NCT02456935    
Other Study ID Numbers: CJ_APA_301
First Posted: May 29, 2015    Key Record Dates
Last Update Posted: December 15, 2016
Last Verified: December 2016
Additional relevant MeSH terms:
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Esophagitis
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action