Erosive EsophagitisPhase 3NCT03006874
Study to Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
A Phase 3 study testing CJ-12420 100mg QD, Esomeprazole 40mg and CJ-12420 50mg 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 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Erosive Esophagitis
- What is being tested?
- CJ-12420 100mg QD, Esomeprazole 40mg and CJ-12420 50mg QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 May 2016to 24 Mar 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Erosive Esophagitis
- Being tested
- CJ-12420 100mg QD, Esomeprazole 40mg, CJ-12420 50mg QD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-12420 100mg QDDrug
Also called Tegoprazan Tab.
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.
Esomeprazole 40mgDrug
Also called Nexium Tab.
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.
CJ-12420 50mg QDDrug
Also called Tegoprazan Tab.
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.
| Study group | Role | What they receive |
|---|---|---|
| CJ-12420 50mg QD | Experimental | CJ-12420 50mg tablet, once daily, oral administration for up to 8 weeks. Receives: Drug: CJ-12420 50mg QD |
| CJ-12420 100mg QD | Experimental | CJ-12420 100mg tablet, once daily, oral administration for up to 8 weeks. Receives: Drug: CJ-12420 100mg QD |
| Esomeprazole 40mg | Active comparator | Esomeprazole 40mg, tablet. once daily, oral administration for up to 8 weeks. Receives: Drug: Esomeprazole 40mg |
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 (3)
Healing rate of erosive esophagitis at 4-week
Measured: 4-week
Symptom assessment by subject diary
Measured: 4-week or 8-week
Symptom assessment by 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 posted30 Dec 2016 (estimated)
- Study start2 May 2016
- Primary completion24 Mar 2017
- Study completion24 Mar 2017
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
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Poong Ryul Lee, Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006874
- Sponsor's protocol ID
- CJ_APA_304
- Status last verified
- Sep 2017
- First submitted
- 14 Jun 2016
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. 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 Confirm the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
- ClinicalTrials.gov ID
- NCT03006874
- Acronym / sponsor ID
- CJ_APA_304
- Conditions
- Erosive Esophagitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 2 May 2016 (actual)
- Primary completion
- 24 Mar 2017 (actual)
- Study completion
- 24 Mar 2017 (actual)
- First posted
- 30 Dec 2016 (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 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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CJ-12420 50mg QD | Experimental | Drug: CJ-12420 50mg QDCJ-12420 50mg tablet, once daily, oral administration for up to 8 weeks. |
| CJ-12420 100mg QD | Experimental | Drug: CJ-12420 100mg QDCJ-12420 100mg tablet, once daily, oral administration for up to 8 weeks. |
| Esomeprazole 40mg | Active comparator | Drug: Esomeprazole 40mgEsomeprazole 40mg, tablet. once daily, oral administration for up to 8 weeks. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 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 100mg QDAlso: Tegoprazan Tab.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. | Drug | CJ-12420 100mg QD |
| Esomeprazole 40mgAlso: Nexium Tab.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. | Drug | Esomeprazole 40mg |
| CJ-12420 50mg QDAlso: Tegoprazan Tab.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. | Drug | CJ-12420 50mg QD |
Primary outcome
Cumulative healing rate of erosive esophagitis at 8-week
Time frame: 8 week
3 secondary outcomes
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
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 12 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Poong Ryul Lee, Ph.D principal investigator
Samsung Medical Center
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 100mg QD, Esomeprazole 40mg and CJ-12420 50mg 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 21 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 12 Sep 2017. 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 12 Sep 2017.