Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
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|ClinicalTrials.gov Identifier: NCT02456935|
Recruitment Status : Completed
First Posted : May 29, 2015
Last Update Posted : December 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Erosive Esophagitis||Drug: CJ-12420 100 mg QD Drug: Esomeprazole 40 mg QD||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||280 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 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|
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
- 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 and questionnaire [ Time Frame: 4 week or 8 week ]
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
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of|
|Principal Investigator:||Hyun Chae Jung, Ph.D||Seoul National University Hospital|