Gastritis
Conditions
Brief 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.
Interventions
None listed
Sponsors
Daewoong Pharmaceutical Co. LTD.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in total subjective symptom score compared to baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in individual subjective symptom score compared to baseline | 2 weeks (maximum 4 weeks) | 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. |
| The effective rate of subjective symptoms compared to baseline | 2 weeks (maximum 4 weeks) | 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. |
| Overall change assessed by study subjects after administration of the study drug | 2 weeks (maximum 4 weeks) | 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. |
| Overall change assessed by the researcher after administration of the drug under study | 2 weeks (maximum 4 weeks) | 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. |
| Adverse events that occurred after administration of Mucotra® extended-release tablets | 2 weeks (maximum 4 weeks) | Adverse events that occurred after administration of Mucotra® extended-release tablets at 2 weeks (maximum 4 weeks) |
Countries
South Korea
Outcome results
None listed