Erosive EsophagitisPhase 3NCT02456935
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
A Phase 3 study testing CJ-12420 100 mg QD and Esomeprazole 40 mg QD in people with Erosive Esophagitis, run by HK inno.N Corporation at 1 site in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- CJ-12420 100 mg QD and Esomeprazole 40 mg QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Sep 2016
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged between 20 and 70 years
- 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
- Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization
- 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.
Who cannot join
- 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
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- Pregnant or lactating women
- 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.
- Subjects who participated in the other clinical trial within 4 weeks prior to randomization
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Erosive Esophagitis
- Being tested
- CJ-12420 100 mg QD, Esomeprazole 40 mg QD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-12420 100 mg QDDrug
Also called Not yet decided
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.
Esomeprazole 40 mg QDDrug
Also called Nexium
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.
| Study group | Role | What they receive |
|---|---|---|
| CJ-12420 100 mg QD | Experimental | CJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks Receives: Drug: CJ-12420 100 mg QD |
| Esomeprazole 40 mg QD | Active comparator | Esomeprazole 40 mg, tablet, once daily, oral administration for up to 8 weeks Receives: Drug: Esomeprazole 40 mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative healing rate of erosive esophagitis at 8-week
Measured: 8 week
Secondary outcomes (2)
Healing rate of erosive esophagitis at 4-week
Measured: 4 week
Symptom assessment by subject diary and questionnaire
Measured: 4 week or 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startMay 2015
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive EsophagitisStudies of the same condition, open and under way.
- More trials run by HK inno.N CorporationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyun Chae Jung, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456935
- Sponsor's protocol ID
- CJ_APA_301
- Status last verified
- Dec 2016
- First submitted
- 27 May 2015
- Last updated
- 15 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02456935
- Acronym / sponsor ID
- CJ_APA_301
- Conditions
- Erosive Esophagitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CJ-12420 100 mg QD | Experimental | Drug: CJ-12420 100 mg QDCJ-12420 100 mg, tablet, once daily, oral administration for up to 8 weeks |
| Esomeprazole 40 mg QD | Active comparator | Drug: Esomeprazole 40 mg QDEsomeprazole 40 mg, tablet, once daily, oral administration for up to 8 weeks |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects aged between 20 and 70 years
- 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
- Endoscopically confirmed erosive esophagitis as defined by LA Classification Grading System (A-D) within 14 days prior to randomization
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CJ-12420 100 mg QDAlso: Not yet decidedCJ-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. | Drug | CJ-12420 100 mg QD |
| Esomeprazole 40 mg QDAlso: NexiumEsomeprazole 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. | Drug | Esomeprazole 40 mg QD |
Primary outcome
Cumulative healing rate of erosive esophagitis at 8-week
Time frame: 8 week
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyun Chae Jung, Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing CJ-12420 100 mg QD and Esomeprazole 40 mg QD in people with Erosive Esophagitis, run by HK inno.N Corporation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative healing rate of erosive esophagitis at 8-week (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2016.