Acute GastritisPhase 3NCT04189705
A Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis
A Phase 3 study testing MCT-SR and Mucosta Tab. in people with Acute Gastritis and Chronic Gastritis, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a multi-center, randomized, double-blind, active-controlled, non-inferiority, phase 3 study to evaluate the efficacy and safety of MCT-SR in patients with gastritis. Read more about this study
- Who is it for?
- Ages 19 to 74 years
- Conditions the study is for
- Acute Gastritis, Chronic Gastritis
- What is being tested?
- MCT-SR and Mucosta Tab.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 Dec 2019to 23 Apr 2020
- 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 19 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females aged ≥19 and <75 years
- Patients diagnosed with acute or chronic gastritis by gastroscopy with at least 1 erosion confirmed by gastroscopy within 7 days prior to the first dose of the Investigational Product(IP)
Who cannot join
- Patients ineligible for gastroscopy
- Patients who took other drugs for treating gastritis within 2 weeks prior to the first dose of the IP.
- Patients who have to continue taking drugs that may induce gastritis
- Other clinically significant medical or psychiatric findings that the investigator considers inappropriate for the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Active-controlled, Non-inferiority, Phase 3 Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis
This is a multi-center, randomized, double-blind, active-controlled, non-inferiority, phase 3 study to evaluate the efficacy and safety of MCT-SR in patients with gastritis.
Read the detailed description
To contribute greater treatment compliance and patient convenience, the rebamipide SR formulation has been developed.
- Conditions
- Acute Gastritis, Chronic Gastritis
- Being tested
- MCT-SR, Mucosta Tab.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCT-SRDrug
Rebamipide 150mg
Mucosta Tab.Drug
Also called Mucosta
Rebamipide 100mg
| Study group | Role | What they receive |
|---|---|---|
| MCT-SR | Experimental | Drug: MCT-SR 2 times/day for 2 weeks Receives: Drug: MCT-SR; Drug: Mucosta Tab. |
| Mucosta Tab. | Active comparator | Drug: Mucosta Tab. 3 times/day for 2 weeks Receives: Drug: MCT-SR; Drug: Mucosta Tab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic Improvement Rate
The percentage of subjects with improvement refer to those with more than 50% improvement in erosion score on gastroscopy after treatment compared to the score before treatment.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2019
- Study start30 Dec 2019
- Primary completion23 Apr 2020
- Study completion23 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute GastritisStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- JaeGyu Kim, Ph.D., Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04189705
- Sponsor's protocol ID
- 037-402-00039
- Status last verified
- Mar 2021
- First submitted
- 25 Nov 2019
- Last updated
- 11 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Active-controlled, Non-inferiority, Phase 3 Study to Evaluate the Efficacy and Safety of MCT-SR in Patients With Gastritis
- ClinicalTrials.gov ID
- NCT04189705
- Acronym / sponsor ID
- 037-402-00039
- Conditions
- Acute Gastritis, Chronic Gastritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2019 (actual)
- Primary completion
- 23 Apr 2020 (actual)
- Study completion
- 23 Apr 2020 (actual)
- First posted
- 6 Dec 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 is a multi-center, randomized, double-blind, active-controlled, non-inferiority, phase 3 study to evaluate the efficacy and safety of MCT-SR in patients with gastritis.
Detailed description
To contribute greater treatment compliance and patient convenience, the rebamipide SR formulation has been developed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCT-SR | Experimental | Drug: MCT-SR, Drug: Mucosta Tab.Drug: MCT-SR 2 times/day for 2 weeks |
| Mucosta Tab. | Active comparator | Drug: MCT-SR, Drug: Mucosta Tab.Drug: Mucosta Tab. 3 times/day for 2 weeks |
Who may qualify
- Ages
- 19 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult males and females aged ≥19 and <75 years
- Patients diagnosed with acute or chronic gastritis by gastroscopy with at least 1 erosion confirmed by gastroscopy within 7 days prior to the first dose of the Investigational Product(IP)
Key exclusion criteria (4 listed)
- Patients ineligible for gastroscopy
- Patients who took other drugs for treating gastritis within 2 weeks prior to the first dose of the IP.
- Patients who have to continue taking drugs that may induce gastritis
- Other clinically significant medical or psychiatric findings that the investigator considers inappropriate for the study
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 |
|---|---|---|
| MCT-SRRebamipide 150mg | Drug | MCT-SR, Mucosta Tab. |
| Mucosta Tab.Also: MucostaRebamipide 100mg | Drug | MCT-SR, Mucosta Tab. |
Primary outcome
Endoscopic Improvement Rate
Time frame: 2 weeks
The percentage of subjects with improvement refer to those with more than 50% improvement in erosion score on gastroscopy after treatment compared to the score before treatment.
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 11 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Acute Gastritis
Not yet recruitingPhase 4
Phase 4 Study of Sto M Tab. in Acute or Chronic Gastritis
Gastritis, Acute Gastritis
RecruitingObservational study
Efficacy and Safety of FEXUCLUE Tab. In Patients With Acute or Chronic Gastritis
Gastritis
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.
JaeGyu Kim, Ph.D. principal investigator
Chung-Ang 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 3 study testing MCT-SR and Mucosta Tab. in people with Acute Gastritis and Chronic Gastritis, run by Korea Otsuka Pharmaceutical Co., Ltd. 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 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 11 Mar 2021. 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 Improvement Rate (time frame: 2 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 11 Mar 2021.