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

NCT06668506 | Completed

• 1 other identifier: MUC0S_OS_01
• Study Type: observational
• Target: 2,814
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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)

Study Arms (1)

Mucotra® SR Tab

Mucotra® SR Tab Rebamipide 150mg

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

Study Sites (1)

Song Kwang Seon Internal medicine clinic

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Gastritis

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: March 17, 2022
• Primary Completion: November 3, 2022
• Study Completion: March 13, 2024
• Last Updated: November 4, 2024

Record last verified: 2024-10

Locations

KR (1)