Gastric UlcerPhase 3NCT02761512
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Gastric Ulcer
A Phase 3 study testing CJ-12420 50 mg QD, CJ-12420 100 mg QD and Lansoprazole 30 mg QD in people with Gastric Ulcer, run by HK inno.N Corporation at 2 sites in South Korea.
Trial summary
To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral administration of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer patients. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastric Ulcer
- What is being tested?
- CJ-12420 50 mg QD, CJ-12420 100 mg QD and Lansoprazole 30 mg QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 2 sitesSouth Korea
- Study dates
- May 2016to 28 Dec 2018
- 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
- 1. Diagnosis of 1 or more active gastric ulcers (≥3 mm ~ ≤30 mm using open biopsy forceps) according to the Sakita-Miwa classification (A1 or A2 stage) from upper GI endoscopy at the same institution within 14 days prior to initiation of the investigational product administration.
Who cannot join
- Finding of gastrointestinal bleeding, esophageal stricture, ulcer stenosis, pyloric stenosis, esophageal gastric varices, Barrett's esophageal of >3 cm (long segment Barrett esophagus, LSBE), duodenal ulcer, intractable ulcer, digestive ulcer perforation or malignancy on upper GI endoscopy.
- Ulcer caused by an endoscopic surgery (e.g., ulcer after EMR/ESD)
- 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
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Catholic Univ. Seoul St. Mary Hospita
Seoul
Kyung Hee University Medical Center
Seoul
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 Gastric Ulcer
To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral administration of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer patients.
Read the detailed description
This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg).
- Conditions
- Gastric Ulcer
- Being tested
- CJ-12420 50 mg QD, CJ-12420 100 mg QD, Lansoprazole 30 mg QD
- Medical subject headings
- Stomach Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CJ-12420 50 mg QDDrug
Also called Not yet decided
CJ-12420 50 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 50 mg.
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 gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 100 mg.
Lansoprazole 30 mg QDDrug
Also called Lanston cap.
Lansoprazole 30 mg capsule will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of Lansoprazole 30 mg.
| Study group | Role | What they receive |
|---|---|---|
| CJ-12420 50 mg QD | Experimental | CJ-12420 50 mg, tablet, once daily, oral administration for up to 8 weeks Receives: Drug: CJ-12420 50 mg QD |
| 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 |
| Lansoprazole 30 mg QD | Active comparator | Lansoprazole 30 mg, capsule, once daily, oral administration for up to 8 weeks Receives: Drug: Lansoprazole 30 mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative healing rate of gastric ulcer at 8-week
Measured: 8 weeks
Secondary outcomes (2)
Healing rate of gastric ulcer at 4-week
Measured: 4 weeks
Week 8 healing rates by H. pylori infection
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMay 2016
- Primary completion26 Jul 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric UlcerStudies 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
- 306 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Myung Gyu Choi, M.D., Ph.D, Principal investigator, Catholic Univ. Seoul St. Mary Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761512
- Sponsor's protocol ID
- CJ_APA_303
- Status last verified
- Apr 2018
- First submitted
- 1 May 2016
- Last updated
- 22 Aug 2019
- 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 22 Aug 2019. 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 Gastric Ulcer
- ClinicalTrials.gov ID
- NCT02761512
- Acronym / sponsor ID
- CJ_APA_303
- Conditions
- Gastric Ulcer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 306 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- May 2016 (actual)
- Primary completion
- 26 Jul 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 4 May 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.
To demonstrate non-inferiority of CJ-12420 to lansoprazole 30 mg capsule in terms of therapeutic efficacy, and to confirm safety of CJ-12420, after once daily oral administration of CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg capsule in gastric ulcer patients.
Detailed description
This is a double blind, randomized, placebo-controlled, phase 3 study. Subjects will be randomly assigned to one of the three treatment groups (CJ-12420 50 mg, 100 mg or Lansoprazole 30 mg).
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 50 mg QD | Experimental | Drug: CJ-12420 50 mg QDCJ-12420 50 mg, tablet, once daily, oral administration for up to 8 weeks |
| 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 |
| Lansoprazole 30 mg QD | Active comparator | Drug: Lansoprazole 30 mg QDLansoprazole 30 mg, capsule, 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 (1 listed)
- 1. Diagnosis of 1 or more active gastric ulcers (≥3 mm ~ ≤30 mm using open biopsy forceps) according to the Sakita-Miwa classification (A1 or A2 stage) from upper GI endoscopy at the same institution within 14 days prior to initiation of the investigational product administration.
Key exclusion criteria (5 listed)
- Finding of gastrointestinal bleeding, esophageal stricture, ulcer stenosis, pyloric stenosis, esophageal gastric varices, Barrett's esophageal of >3 cm (long segment Barrett esophagus, LSBE), duodenal ulcer, intractable ulcer, digestive ulcer perforation or malignancy on upper GI endoscopy.
- Ulcer caused by an endoscopic surgery (e.g., ulcer after EMR/ESD)
- 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
- 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
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 50 mg QDAlso: Not yet decidedCJ-12420 50 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 50 mg. | Drug | CJ-12420 50 mg QD |
| 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 gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 100 mg. | Drug | CJ-12420 100 mg QD |
| Lansoprazole 30 mg QDAlso: Lanston cap.Lansoprazole 30 mg capsule will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of Lansoprazole 30 mg. | Drug | Lansoprazole 30 mg QD |
Primary outcome
Cumulative healing rate of gastric ulcer at 8-week
Time frame: 8 weeks
2 secondary outcomes
Healing rate of gastric ulcer at 4-week
Time frame: 4 weeks
Week 8 healing rates by H. pylori infection
Time frame: 8 weeks
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 22 Aug 2019.
- 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.
Myung Gyu Choi, M.D., Ph.D principal investigator
Catholic Univ. Seoul St. Mary Hospital
2 sites 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 50 mg QD, CJ-12420 100 mg QD and Lansoprazole 30 mg QD in people with Gastric Ulcer, run by HK inno.N Corporation at 2 sites 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 1 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 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 gastric ulcer at 8-week (time frame: 8 weeks). 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 22 Aug 2019.