Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
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|ClinicalTrials.gov Identifier: NCT03006874|
Recruitment Status : Completed
First Posted : December 30, 2016
Last Update Posted : September 12, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Erosive Esophagitis||Drug: CJ-12420 100mg QD Drug: Esomeprazole 40mg Drug: CJ-12420 50mg QD||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||302 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
- Cumulative healing rate of erosive esophagitis at 8-week [ Time Frame: 8 week ]
- Healing rate of erosive esophagitis at 4-week [ Time Frame: 4-week ]
- Symptom assessment by subject diary [ Time Frame: 4-week or 8-week ]
- Symptom assessment by questionnaire [ Time Frame: 4-week or 8-week ]
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.
|Ages Eligible for Study:||20 Years to 75 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Subjects aged between 20 and 75 years
- Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization
- Subjects who had experienced heartburn and regurgitation within 7 days before visit 1
- Subjects who is able to understand and follow the instructions and is willing to participate throughout the entire study
- Subjects who voluntarily signed written informed consent form
- Subjects who agreed to use medically acceptable contraceptives during the period of study
- Subjects who cannot undergo EGD
- Subjects who have esophageal stenosis, ulcer stenosis, gastroesophageal varices, Barrett's esophagus, active gastric ulcer, gastrointestinal bleeding or malignant tumor confirmed by EGD
- Subjects who have warning symptoms of malignant gastrointestinal tract such as odynophagia, severe dysphagia, bleeding, weight loss, anemia, or bloody stool
- Subjects with eosinophilic esophagitis
- Subjects diagnosed with primary esophageal motility disorder, IBS, IBD, etc. or with suspected IBS in the last 3 months
- Subjects who have a history of gastric acid suppression surgery or upper gastrointestinal, esophageal surgery
- Subjects who have AIDS or Hepatitis
- Subjects who take antipsychotic drugs, antidepressant drug, antianxiety drug
- Subjects who take gastric acid suppression like PPI within 2 weeks to EGD
- Subjects who take medications related to reflux esophagitis more than 2 times within 1 weeks to EGD
- 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
- Pregnant or lactating women
- Subjects with the following clinically significant laboratory abnormalities
- Subjects with the following clinically significant ECG abnormalities
- Sollinger-Ellison syndrome patients
- Subjects with a history of malignant tumor
- Subjects with a history of clinically significant hepatic, renal, cardiovascular, respiratory, endocrine and CNS system disorder
- Subjects with a history of hypersensitivity to the active ingredient or excipients of the study drug, etc
- Scheduled surgery requiring hospitalization or requirement of surgical treatment during study participation
- Subjects who participated in the other clinical trial within 4 weeks prior to randomization
- Subjects who are judged unsuitable to participate in the study in the opinion of the investigator
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
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Principal Investigator:||Poong Ryul Lee, Ph.D||Samsung Medical Center|
|Responsible Party:||HK inno.N Corporation|
|Other Study ID Numbers:||
|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|
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