Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Confirm 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: NCT03006874
Recruitment Status : Completed
First Posted : December 30, 2016
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
HK inno.N Corporation

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to confirm 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 100mg QD Drug: Esomeprazole 40mg Drug: CJ-12420 50mg 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 three treatment groups (CJ-12420 50mg, CJ-12420 100mg, esomeprazole 40mg).

All subjects will be asked to take three 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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 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 Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
Actual Study Start Date : May 2, 2016
Actual Primary Completion Date : March 24, 2017
Actual Study Completion Date : March 24, 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: CJ-12420 50mg QD
CJ-12420 50mg tablet, once daily, oral administration for up to 8 weeks.
 Drug: CJ-12420 50mg QD
CJ-12420 50mg 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 50mg.
Other Name: Tegoprazan Tab.
Experimental: CJ-12420 100mg QD
CJ-12420 100mg tablet, once daily, oral administration for up to 8 weeks.
 Drug: CJ-12420 100mg QD
CJ-12420 100mg 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 100mg.
Other Name: Tegoprazan Tab.
Active Comparator: Esomeprazole 40mg
Esomeprazole 40mg, tablet. once daily, oral administration for up to 8 weeks.
 Drug: Esomeprazole 40mg
Esomeprazole 40mg 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 40mg.
Other Name: Nexium Tab.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 [ Time Frame: 4-week or 8-week ]
  3. Symptom assessment by questionnaire [ Time Frame: 4-week or 8-week ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects aged between 20 and 75 years
  2. Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization
  3. Subjects who had experienced heartburn and regurgitation within 7 days before visit 1
  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. Subjects who have AIDS or Hepatitis
  8. Subjects who take antipsychotic drugs, antidepressant drug, antianxiety drug
  9. Subjects who take gastric acid suppression like PPI within 2 weeks to EGD
  10. Subjects who take medications related to reflux esophagitis more than 2 times within 1 weeks to EGD
  11. Requirement of persistent daily use of drugs that may cause an ulcer such as nonsteroidal anti-inflammatory drugs(NSAIDs) or aspirin during the course of the study
  12. Pregnant or lactating women
  13. Subjects with the following clinically significant laboratory abnormalities
  14. Subjects with the following clinically significant ECG abnormalities
  15. Sollinger-Ellison syndrome patients
  16. Subjects with a history of malignant tumor
  17. Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder
  18. Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc
  19. Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation
  20. Subjects who participated in the other clinical trial within 4 weeks prior to randomization
  21. Subjects who are judged unsuitable to participate in the study in the opinion of the investigator
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT03006874


Locations
Layout table for location information
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
HK inno.N Corporation
Investigators
Layout table for investigator information
Principal Investigator: Poong Ryul Lee, Ph.D Samsung Medical Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: HK inno.N Corporation
ClinicalTrials.gov Identifier: NCT03006874    
Other Study ID Numbers: CJ_APA_304
First Posted: December 30, 2016    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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