Erosive EsophagitisPhase 2NCT02028663
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
A Phase 2 study testing CJ-12420 and Esomeprazole in people with Erosive Esophagitis and GERD, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the optimal dose and administration methods of CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally administered CJ-12420 to esomeprazole 40mg. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Erosive Esophagitis, GERD
- What is being tested?
- CJ-12420 and Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 206 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2013to May 2014
- Phase
- Phase 2
- 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
- Aged between 20-70
- Diagnosed with Erosive Esophagitis by Esophagogastroduodenoscopy (EGD) and classified into LA Grade A to D within 14 days before randomization to treatment
Who cannot join
- Patients who cannot undergo EGD
- Patients diagnosed with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected IBS
- Patients who took PPIs within 2 weeks prior to study drug administration
- Long-term use of nonsteroidal anti-inflammatory drugs throughout the study
- Clinically significant abnormal laboratory values during screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-Blind, Randomized, Dose-finding Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
The purpose of this study is to investigate the optimal dose and administration methods of CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally administered CJ-12420 to esomeprazole 40mg.
- Conditions
- Erosive Esophagitis, GERD
- Being tested
- CJ-12420, Esomeprazole
- Keywords
- P-CAB, APA(Acid Pump Antagonist)
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-12420Drug
Also called Undecided
Once daily, Oral administration
EsomeprazoleDrug
Also called Nexium
Once daily, Oral administration
| Study group | Role | What they receive |
|---|---|---|
| CJ-12420 Amg | Experimental | 50 volunteers will be administered CJ-12420 Amg Receives: Drug: CJ-12420 |
| CJ-12420 Bmg | Experimental | 50 volunteers will be administered CJ-12420 Bmg Receives: Drug: CJ-12420 |
| CJ-12420 Cmg | Experimental | 50 volunteers will be administered CJ-12420 Cmg Receives: Drug: CJ-12420 |
| Esomeprazole 40mg | Active comparator | 50 volunteers will be administered Esomeprazole 40mg Receives: Drug: Esomeprazole |
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 (1)
Healing rate of erosive esophagitis at 4-week
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startMay 2013
- Primary completionMay 2014
- Study completionMay 2014
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyun-Chae Jung, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028663
- Sponsor's protocol ID
- CJ_APA_201
- Status last verified
- Aug 2014
- First submitted
- 5 Jan 2014
- Last updated
- 8 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Dose-finding Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
- ClinicalTrials.gov ID
- NCT02028663
- Acronym / sponsor ID
- CJ_APA_201
- Conditions
- Erosive Esophagitis, GERD
- Keywords
- P-CAB, APA(Acid Pump Antagonist)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Jan 2014 (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 investigate the optimal dose and administration methods of CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally administered CJ-12420 to esomeprazole 40mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CJ-12420 Amg | Experimental | Drug: CJ-1242050 volunteers will be administered CJ-12420 Amg |
| CJ-12420 Bmg | Experimental | Drug: CJ-1242050 volunteers will be administered CJ-12420 Bmg |
| CJ-12420 Cmg | Experimental | Drug: CJ-1242050 volunteers will be administered CJ-12420 Cmg |
| Esomeprazole 40mg | Active comparator | Drug: Esomeprazole50 volunteers will be administered Esomeprazole 40mg |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 20-70
- Diagnosed with Erosive Esophagitis by Esophagogastroduodenoscopy (EGD) and classified into LA Grade A to D within 14 days before randomization to treatment
Key exclusion criteria (5 listed)
- Patients who cannot undergo EGD
- Patients diagnosed with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), or suspected IBS
- Patients who took PPIs within 2 weeks prior to study drug administration
- Long-term use of nonsteroidal anti-inflammatory drugs throughout the study
- Clinically significant abnormal laboratory values during screening
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-12420Also: UndecidedOnce daily, Oral administration | Drug | CJ-12420 Amg, CJ-12420 Bmg, CJ-12420 Cmg |
| EsomeprazoleAlso: NexiumOnce daily, Oral administration | Drug | Esomeprazole 40mg |
Primary outcome
Cumulative healing rate of erosive esophagitis at 8-week
Time frame: 8 week
1 secondary outcome
Healing rate of erosive esophagitis at 4-week
Time frame: 4 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 8 Aug 2014.
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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, MD, PhD 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 2 study testing CJ-12420 and Esomeprazole in people with Erosive Esophagitis and GERD, 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 2 inclusion and 5 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 8 Aug 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 8 Aug 2014.