GastritisNCT06668506
To Evaluate Improvement Effect of Subjective Symptoms of Mucotra SR Tablet in Patients With Gastritis
An observational study of Gastritis, run by Daewoong Pharmaceutical Co. LTD. at 1 site in South Korea.
Trial summary
This study aims to evaluate the improvement effect on subjective symptoms of gastritis and adverse events through patient self-assessment results (PRO) by conducting follow-up observations for patients with gastritis at 2 to 4 weeks after administration of Mucotra® SR tablets. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Gastritis
- How many people
- 2,814 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Mar 2022to 13 Mar 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: The minimum number of study subjects required to estimate the two-sided 95% confidence interval of the change in the total score of subjective symptoms at 2 weeks compared to the baseline as -3.19 to 2.99, with the standard deviation assumed by referring to the AD-203P3 literature, is calculated to be 15,247 ( PASS 13. NCSS, LLC. (Kailsville, Utah, USA)
Who may be able to join
- Men or women aged ≥ 19 years
- Subjects with acute or chronic gastritis, requiring treatment with Mucotra® SR tab
- Subjects with subjective symptoms
- Subjects who voluntarily consent to participate in this observational study
Who cannot join
- Subjects who have had a hypersensitivity reaction to the components of Mucotra® SR tab
- Subject with genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-center, Prospective, Observational Study to Evaluate Improvement Effect of Subjective Symptoms of Mucotra SR Tablet in Patients With Gastritis
This study aims to evaluate the improvement effect on subjective symptoms of gastritis and adverse events through patient self-assessment results (PRO) by conducting follow-up observations for patients with gastritis at 2 to 4 weeks after administration of Mucotra® SR tablets.
- Conditions
- Gastritis
- Medical subject headings
- Gastritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mucotra® SR Tab | Mucotra® SR Tab Rebamipide 150mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total subjective symptom score compared to baseline
Change in total subjective symptom score compared to baseline at 2 weeks (up to 4 weeks) on a scale of 0 to 3 points for 8 items (epigastric pain, severe pain, nausea/vomiting, acid reflux, bloating, poor appetite, heartburn, burping). Higher scores are indicative of more severe symptoms.
Measured: 2 weeks (up to 4 weeks)
Secondary outcomes (5)
Change in individual subjective symptom score compared to baseline
Change in individual subjective symptom score compared to baseline at 2 weeks (up to 4 weeks) on a scale of 0 to 3 points for 8 items (epigastric pain, severe pain, nausea/vomiting, acid reflux, bloating, poor appetite, heartburn, burping). Higher scores are indicative of more severe symptoms.
Measured: 2 weeks (maximum 4 weeks)
The effective rate of subjective symptoms compared to baseline
The effective rate of subjective symptoms compared to baseline at 2 weeks (maximum 4 weeks). The effective rate is the percentage of patients whose total subjective symptom scores are reduced by more than 50% compared to their scores before administration.
Measured: 2 weeks (maximum 4 weeks)
Overall change assessed by study subjects after administration of the study drug
Overall change assessed by study subjects after administration of the study drug at 2 weeks. (maximum 4 weeks) The overall change is assessed using five criteria: very much improved, much improved, minimally improved, no change, and worse.
Measured: 2 weeks (maximum 4 weeks)
Overall change assessed by the researcher after administration of the drug under study
Overall change assessed by the researcher after administration of the drug under study at 2 weeks (maximum 4 weeks). The overall change is assessed using five criteria: very much improved, much improved, minimally improved, no change, and worse.
Measured: 2 weeks (maximum 4 weeks)
Adverse events that occurred after administration of Mucotra® extended-release tablets
Adverse events that occurred after administration of Mucotra® extended-release tablets at 2 weeks (maximum 4 weeks)
Measured: 2 weeks (maximum 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2024
- Study start17 Mar 2022
- Primary completion3 Nov 2022
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastritisStudies of the same condition, open and under way.
- More trials run by Daewoong Pharmaceutical Co. LTD.The 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2,814 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06668506
- Sponsor's protocol ID
- MUC0S_OS_01
- Status last verified
- Oct 2024
- First submitted
- 30 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Prospective, Observational Study to Evaluate Improvement Effect of Subjective Symptoms of Mucotra SR Tablet in Patients With Gastritis
- ClinicalTrials.gov ID
- NCT06668506
- Acronym / sponsor ID
- MUC0S_OS_01
- Conditions
- Gastritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,814 participants (actual)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2022 (actual)
- Primary completion
- 3 Nov 2022 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 31 Oct 2024 (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 evaluate the improvement effect on subjective symptoms of gastritis and adverse events through patient self-assessment results (PRO) by conducting follow-up observations for patients with gastritis at 2 to 4 weeks after administration of Mucotra® SR tablets.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mucotra® SR Tab | – | –Mucotra® SR Tab Rebamipide 150mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The minimum number of study subjects required to estimate the two-sided 95% confidence interval of the change in the total score of subjective symptoms at 2 weeks compared to the baseline as -3.19 to 2.99, with the standard deviation assumed by referring to the AD-203P3 literature, is calculated to be 15,247 ( PASS 13. NCSS, LLC. (Kailsville, Utah, USA)
Key inclusion criteria (4 listed)
- Men or women aged ≥ 19 years
- Subjects with acute or chronic gastritis, requiring treatment with Mucotra® SR tab
- Subjects with subjective symptoms
- Subjects who voluntarily consent to participate in this observational study
Key exclusion criteria (2 listed)
- Subjects who have had a hypersensitivity reaction to the components of Mucotra® SR tab
- Subject with genetic disorders such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in total subjective symptom score compared to baseline
Time frame: 2 weeks (up to 4 weeks)
Change in total subjective symptom score compared to baseline at 2 weeks (up to 4 weeks) on a scale of 0 to 3 points for 8 items (epigastric pain, severe pain, nausea/vomiting, acid reflux, bloating, poor appetite, heartburn, burping). Higher scores are indicative of more severe symptoms.
5 secondary outcomes
Change in individual subjective symptom score compared to baseline
Time frame: 2 weeks (maximum 4 weeks)
The effective rate of subjective symptoms compared to baseline
Time frame: 2 weeks (maximum 4 weeks)
Overall change assessed by study subjects after administration of the study drug
Time frame: 2 weeks (maximum 4 weeks)
Overall change assessed by the researcher after administration of the drug under study
Time frame: 2 weeks (maximum 4 weeks)
Adverse events that occurred after administration of Mucotra® extended-release tablets
Time frame: 2 weeks (maximum 4 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 4 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Gastritis, run by Daewoong 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 4 inclusion and 2 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 4 Nov 2024. 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?
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?
Change in total subjective symptom score compared to baseline (time frame: 2 weeks (up to 4 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 4 Nov 2024.