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

Completed

• Conditions: Gastritis

• Registration Number: NCT06668506
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-17
• Primary Completion: 2022-11-03
• Study Completion: 2024-03-13
• Status Verified: 2024-10
• Study First Submitted: 2024-10-30
• Study First Submitted QC: 2024-10-30
• Study First Posted: 2024-10-31
• Last Update Submitted: 2024-10-31
• Last Update Posted: 2024-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2814

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Song Kwang Seon Internal medicine clinic; 🇰🇷 Wonju, Korea, Republic of