To Evaluate Improvement Effect of Subjective Symptoms of Mucotra SR Tablet in Patients With Gastritis

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.

Study Overview

• Status: Completed
• Conditions: Gastritis

• Study Type: Observational
• Enrollment (Actual): 2814

Contacts and Locations

Study Locations

• Korea, Republic of
  • Wonju, Korea, Republic of
    • Song Kwang Seon Internal medicine clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Mucotra® SR Tab; Mucotra® SR Tab Rebamipide 150mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 weeks (up to 4 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2 weeks (maximum 4 weeks)
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.	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.	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.	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.	2 weeks (maximum 4 weeks)

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.

Study record dates

Study Major Dates

• Study Start (Actual): March 17, 2022
• Primary Completion (Actual): November 3, 2022
• Study Completion (Actual): March 13, 2024

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: October 30, 2024
• First Posted (Actual): October 31, 2024

Study Record Updates

• Last Update Posted (Estimated): November 4, 2024
• Last Update Submitted That Met QC Criteria: October 31, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis
• Other Study ID Numbers: MUC0S_OS_01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No