Healed Erosive EsophagitisPhase 3NCT04022096
Study to Confirm the Safety and Efficacy of Tegoprazan in Patients With Healed Erosive Esophagitis
A Phase 3 study testing Tegoprazan 25mg QD and Lansoprazole 15mg QD in people with Healed Erosive Esophagitis, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Healed Erosive Esophagitis
- What is being tested?
- Tegoprazan 25mg QD and Lansoprazole 15mg QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 351 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Jun 2019to 23 Jun 2021
- 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
- Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization
- Healed erosive esophagitis within 7 days prior to Randomization
- No heartburn and regurgitation within 7 days prior to Randomization
Who cannot join
- Unable to undergo upper GI endoscopy
- Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with >3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy
- Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)
- History of acid-suppressive, esophageal or gastric surgeries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of Tegoprazan as Maintenance Therapy in Patients With Healed Erosive Esophagitis
This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.
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 (tegoprazan 25mg, lansoprazole 15mg).
- Conditions
- Healed Erosive Esophagitis
- Being tested
- Tegoprazan 25mg QD, Lansoprazole 15mg QD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tegoprazan 25mg QDDrug
Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months.
Lansoprazole 15mg QDDrug
Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan 25mg QD | Experimental | Tegoprazan 25mg tablet, once daily, oral administration Receives: Drug: Tegoprazan 25mg QD |
| Lansoprazole 15mg QD | Active comparator | Lansoprazole 15mg capsule, once daily, oral administration Receives: Drug: Lansoprazole 15mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic remission rate of EE at 24-week
Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks)
Measured: 24-week
Secondary outcomes (1)
Endoscopic remission rate of EE at 12-week
Endoscopic remission: No endoscopic recurrence of erosion(LA grades A to D) during maintenance period(12 weeks)
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2019
- Study start18 Jun 2019
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healed 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
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Oh Young Lee, Ph.D, Principal investigator, Hanyang University Seoul Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022096
- Sponsor's protocol ID
- CJ_APA_305
- Status last verified
- Jan 2023
- First submitted
- 14 Jul 2019
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-blind, Randomized, Active-controlled Study to Evaluate the Safety and Efficacy of Tegoprazan as Maintenance Therapy in Patients With Healed Erosive Esophagitis
- ClinicalTrials.gov ID
- NCT04022096
- Acronym / sponsor ID
- CJ_APA_305
- Conditions
- Healed Erosive Esophagitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 16 Jul 2019 (actual)
- 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.
This study is designed to confirm the non-inferiority of Tegoprazan 25mg, compared to Lansoprazole 15mg as maintenance therapy in patients with healed erosive esophagitis confirmed by endoscopy following oral administration once daily(QD) for 6 months.
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 (tegoprazan 25mg, lansoprazole 15mg).
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 |
|---|---|---|
| Tegoprazan 25mg QD | Experimental | Drug: Tegoprazan 25mg QDTegoprazan 25mg tablet, once daily, oral administration |
| Lansoprazole 15mg QD | Active comparator | Drug: Lansoprazole 15mg QDLansoprazole 15mg capsule, once daily, oral administration |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Erosive eshophagitis(LA classification Grades A to D) within 12 weeks prior to Randomization
- Healed erosive esophagitis within 7 days prior to Randomization
- No heartburn and regurgitation within 7 days prior to Randomization
Key exclusion criteria (4 listed)
- Unable to undergo upper GI endoscopy
- Presence of esophageal stricture, ulcerated stricture, gastroesophageal varix, long segment Barrett's esophagus with >3 cm length(LSBE), active digestive ulcer, gastric bleeding or malignant tumors on an upper GI endoscopy
- Diagnosed with primary esophageal motility disorder, irritable bowel syndome(IBS) or inflammatory bowel disease(IBD)
- History of acid-suppressive, esophageal or gastric surgeries
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 |
|---|---|---|
| Tegoprazan 25mg QDTegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months. | Drug | Tegoprazan 25mg QD |
| Lansoprazole 15mg QDLansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months. | Drug | Lansoprazole 15mg QD |
Primary outcome
Endoscopic remission rate of EE at 24-week
Time frame: 24-week
Endoscopic remission: No endoscopic recurrence of erosion(LA grade A to D) during maintenance period(24 weeks)
1 secondary outcome
Endoscopic remission rate of EE at 12-week
Time frame: 12-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 27 Jan 2023.
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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.
Oh Young Lee, Ph.D principal investigator
Hanyang University Seoul 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 Tegoprazan 25mg QD and Lansoprazole 15mg QD in people with Healed 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 3 inclusion and 4 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 27 Jan 2023. 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?
Endoscopic remission rate of EE at 24-week (time frame: 24-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 27 Jan 2023.