A Multi-center, Prospective, Observational Study to Evaluate Improvement Effect of Subjective Symptoms of Mucotra SR Tablet in Patients With Gastritis

Daewoong Pharmaceutical Co. LTD.1 site in 1 country2,814 target enrollmentMarch 17, 2022

ConditionsGastritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Gastritis
Sponsor: Daewoong Pharmaceutical Co. LTD.
Enrollment: 2814
Locations: 1
Primary Endpoint: Change in total subjective symptom score compared to baseline
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 17, 2022

End Date

March 13, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Daewoong Pharmaceutical Co. LTD.

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Change in individual subjective symptom score compared to baseline(2 weeks (maximum 4 weeks))
The effective rate of subjective symptoms compared to baseline(2 weeks (maximum 4 weeks))
Overall change assessed by study subjects after administration of the study drug(2 weeks (maximum 4 weeks))
Overall change assessed by the researcher after administration of the drug under study(2 weeks (maximum 4 weeks))
Adverse events that occurred after administration of Mucotra® extended-release tablets(2 weeks (maximum 4 weeks))