Erosive Reflux DiseasePhase 4NCT04309916
Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
A Phase 4 study testing Tegoprazan and Esomeprazole in people with Erosive Reflux Disease, run by HK inno.N Corporation at 1 site in South Korea.
Trial summary
This study aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients. Read more about this study
- Who is it for?
- Ages 19 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Erosive Reflux Disease
- What is being tested?
- Tegoprazan and Esomeprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 May 2020to 30 Nov 2021
- Phase
- Phase 4
- 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 19 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects aged between 19 and 75 years
- Subjects who have erosive reflux disease
Who cannot join
- Unable to undergo upper GI endoscopy
- Symptoms of primary or secondary esophageal movement disorders
- Planning or Perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, Vagotomy, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 (Pilot) Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
This study aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.
Read the detailed description
This is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg)
- Conditions
- Erosive Reflux Disease
- Being tested
- Tegoprazan, Esomeprazole
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TegoprazanDrug
Tegoprazan 50mg tablet
EsomeprazoleDrug
Esomeprazole 40mg tablet
| Study group | Role | What they receive |
|---|---|---|
| Tegoprazan 50mg | Experimental | Tegoprazan 50mg tablet, once daily, oral administration Receives: Drug: Tegoprazan |
| Esomeprazole 40mg | Active comparator | Esomeprazole 40mg tablet, once daily, oral administration Receives: Drug: Esomeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first nighttime heartburn-free interval (days))
Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials.
Measured: 2 week
Secondary outcomes (1)
Percentage of days without nighttime heartburn during the 2-week dosing period
Percentage of days without nighttime heartburn = Number of days without nighttime heartburn symptoms during the dosing period / Number of days when nighttime heartburn was assessed x 100
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start22 May 2020
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive Reflux DiseaseStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- HK inno.N Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sang Kil Lee, Ph.D, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309916
- Sponsor's protocol ID
- KCAB_002
- Status last verified
- Feb 2022
- First submitted
- 13 Mar 2020
- Last updated
- 25 Feb 2022
- 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 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-blind, Randomized, Active-controlled Phase 4 (Pilot) Study to Evaluate the Efficacy and Safety of Tegoprazan in ERD Patients With Nighttime Heartburn and Sleep Disturbance
- ClinicalTrials.gov ID
- NCT04309916
- Acronym / sponsor ID
- KCAB_002
- Conditions
- Erosive Reflux Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- HK inno.N CorporationIndustry (pharma, biotech, devices)
- Study start
- 22 May 2020 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 17 Mar 2020 (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 aims to compare the nighttime heartburn and sleep disturbance improvement effect of Tegoprazan 50mg and Eomeprazole 40mg in patients with ERD patients.
Detailed description
This is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study. Subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg)
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 50mg | Experimental | Drug: TegoprazanTegoprazan 50mg tablet, once daily, oral administration |
| Esomeprazole 40mg | Active comparator | Drug: EsomeprazoleEsomeprazole 40mg tablet, once daily, oral administration |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects aged between 19 and 75 years
- Subjects who have erosive reflux disease
Key exclusion criteria (3 listed)
- Unable to undergo upper GI endoscopy
- Symptoms of primary or secondary esophageal movement disorders
- Planning or Perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, Vagotomy, etc.)
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 |
|---|---|---|
| TegoprazanTegoprazan 50mg tablet | Drug | Tegoprazan 50mg |
| EsomeprazoleEsomeprazole 40mg tablet | Drug | Esomeprazole 40mg |
Primary outcome
Time to first nighttime heartburn-free interval (days))
Time frame: 2 week
Number of days to reach the without symptoms of nighttime heartburn after the start of drug administration for clinical trials.
1 secondary outcome
Percentage of days without nighttime heartburn during the 2-week dosing period
Time frame: 2 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 25 Feb 2022.
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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.
Sang Kil Lee, Ph.D principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tegoprazan and Esomeprazole in people with Erosive Reflux Disease, 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 3 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 25 Feb 2022. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Time to first nighttime heartburn-free interval (days)) (time frame: 2 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 25 Feb 2022.