Acute GastritisMCTSRPMSNCT05048069
Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab.
An observational study of Acute Gastritis and Chronic Gastritis, run by Korea Otsuka Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This PMS is a non-interventional, prospective, single-arm, multi-center surveillance in accordance with Korean regulation, 'Standard for Re-Examination of New Drugs'. This PMS is to assess the safety and effectiveness after administrating Mucosta®SR Tab. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Gastritis, Chronic Gastritis
- What is being tested?
- Mucosta®SR Tablets 150mg(Rebamipide)
- Type of treatment
- Pill or oral medicine
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Oct 2021to 15 Dec 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) of acute gastritis or acute exacerbation of chronic gastritis prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.
Who may be able to join
- Adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) in acute gastritis or acute exacerbation of chronic gastritis.
- Patients prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.
- Patients who have given a written informed consent to participation of this PMS and use of personal information after execution of the contract with the surveillance study site.
Who cannot join
- Patients with prior history of prescription with Mucosta®SR Tab.
- Patients with hypersensitivity to Rebamipide or its component ingredients.
- Patients deemed not suitable for surveillance enrollment according to investigator's medical judgment
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Soon Chun Hyang University Hospital Seoul
Seoul
Yumi An, 02-709-9222, s3701@schmc.ac.kr
Seongran Jeon
About this study
Official title: Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab. in Korean Patients With Acute or Chronic Gastritis in Accordance With Korean Regulation, 'Standard for Re-examination of New Drugs'
This PMS is a non-interventional, prospective, single-arm, multi-center surveillance in accordance with Korean regulation, 'Standard for Re-Examination of New Drugs'. This PMS is to assess the safety and effectiveness after administrating Mucosta®SR Tab. Each subject would be observed for 2 weeks from baseline, if possible. As this PMS is an observational study in practical medical environment, the subject's follow-up is recommended but not obligatory and must be left up to the judgment of the investigator.
Read the detailed description
According to the "Standards for Re-examination of New Drugs, etc." of South Korea, this PMS is conducted in order to collect safety and efficacy information for patients prescribed with Mucosta®SR Tab. under actual conditions of treatment during the re-examination period of Mucosta®SR Tab. 150mg (Rebamipide)
- Conditions
- Acute Gastritis, Chronic Gastritis
- Being tested
- Mucosta®SR Tablets 150mg(Rebamipide)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mucosta®SR Tablets 150mg(Rebamipide)Drug
adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) of acute gastritis or acute exacerbation of chronic gastritis prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall clinical improvement
Improved, No change, Worse The effective rate is defined as the percentage of subjects classified as 'Improved'.
Measured: at 2 weeks of treatment
the incidence rate and the number of cases for adverse events (AEs)
Measured: Safety information that occurred from the first administration to 3 days after discontinuation will be collected.
Secondary outcomes (2)
Endoscopic improvement rate
If upper GI endoscopy is performed at baseline and follow-up visits, the erosion score will be assessed and endoscopic improvement rate at 2 weeks will be evaluated. Endoscopic improvement rate is defined as ≥50% reduction of the erosion score.
Measured: at baseline and 2 weeks
Gastric symptoms
Presence and type of gastric symptoms at baseline and 2 weeks will be collected.
Measured: at baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2021
- Study start7 Oct 2021
- Primary completion15 Dec 2024 (estimated)
- Study completion15 Dec 2024 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048069
- Sponsor's protocol ID
- 037-402-00047
- Acronym
- MCTSRPMS
- Status last verified
- Sep 2023
- First submitted
- 24 Aug 2021
- Last updated
- 28 Sep 2023
- 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 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab. in Korean Patients With Acute or Chronic Gastritis in Accordance With Korean Regulation, 'Standard for Re-examination of New Drugs'
- ClinicalTrials.gov ID
- NCT05048069
- Acronym / sponsor ID
- MCTSRPMS / 037-402-00047
- Conditions
- Acute Gastritis, Chronic Gastritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- 15 Dec 2024 (estimated)
- Study completion
- 15 Dec 2024 (estimated)
- First posted
- 17 Sep 2021 (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 PMS is a non-interventional, prospective, single-arm, multi-center surveillance in accordance with Korean regulation, 'Standard for Re-Examination of New Drugs'. This PMS is to assess the safety and effectiveness after administrating Mucosta®SR Tab. Each subject would be observed for 2 weeks from baseline, if possible. As this PMS is an observational study in practical medical environment, the subject's follow-up is recommended but not obligatory and must be left up to the judgment of the investigator.
Detailed description
According to the "Standards for Re-examination of New Drugs, etc." of South Korea, this PMS is conducted in order to collect safety and efficacy information for patients prescribed with Mucosta®SR Tab. under actual conditions of treatment during the re-examination period of Mucosta®SR Tab. 150mg (Rebamipide)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) of acute gastritis or acute exacerbation of chronic gastritis prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.
Key inclusion criteria (3 listed)
- Adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) in acute gastritis or acute exacerbation of chronic gastritis.
- Patients prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.
- Patients who have given a written informed consent to participation of this PMS and use of personal information after execution of the contract with the surveillance study site.
Key exclusion criteria (3 listed)
- Patients with prior history of prescription with Mucosta®SR Tab.
- Patients with hypersensitivity to Rebamipide or its component ingredients.
- Patients deemed not suitable for surveillance enrollment according to investigator's medical judgment
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 |
|---|---|---|
| Mucosta®SR Tablets 150mg(Rebamipide)adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) of acute gastritis or acute exacerbation of chronic gastritis prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator. | Drug | – |
Primary outcome
Overall clinical improvement
Time frame: at 2 weeks of treatment
Improved, No change, Worse The effective rate is defined as the percentage of subjects classified as 'Improved'.
the incidence rate and the number of cases for adverse events (AEs)
Time frame: Safety information that occurred from the first administration to 3 days after discontinuation will be collected.
2 secondary outcomes
Endoscopic improvement rate
Time frame: at baseline and 2 weeks
Gastric symptoms
Time frame: at baseline and 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 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: status not confirmed, as of the sponsor's last update on 28 Sep 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jisu Yang (010-3188-9178, js.yang@otsuka.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall clinical improvement (time frame: at 2 weeks of treatment). The study lists 2 primary outcomes in all. 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 28 Sep 2023.