Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab.

NCT05048069 | Unknown

• 1 other identifier: 037-402-00047
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This PMS is a non-interventional, prospective, single-arm, multi-center surveillance in accordance with Korean regulation, 'Standard for Re-Examination of New Drugs'. This PMS is to assess the safety and effectiveness after administrating Mucosta®SR Tab. Each subject would be observed for 2 weeks from baseline, if possible. As this PMS is an observational study in practical medical environment, the subject's follow-up is recommended but not obligatory and must be left up to the judgment of the investigator.

Conditions

Acute Gastritis; Chronic Gastritis

Outcome Measures

Primary Outcomes (2)

• Overall clinical improvement

  Improved, No change, Worse The effective rate is defined as the percentage of subjects classified as 'Improved'.

  at 2 weeks of treatment

• the incidence rate and the number of cases for adverse events (AEs)

  Safety information that occurred from the first administration to 3 days after discontinuation will be collected.

Secondary Outcomes (2)

• Endoscopic improvement rate

  at baseline and 2 weeks

• Gastric symptoms

  at baseline and 2 weeks

Interventions

Mucosta®SR Tablets 150mg(Rebamipide) DRUG

adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) of acute gastritis or acute exacerbation of chronic gastritis prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.

Eligibility Criteria

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

Study Population

Adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) of acute gastritis or acute exacerbation of chronic gastritis prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.

You may qualify if:

• Adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) in acute gastritis or acute exacerbation of chronic gastritis.
• Patients prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.
• Patients who have given a written informed consent to participation of this PMS and use of personal information after execution of the contract with the surveillance study site.

You may not qualify if:

• Patients with prior history of prescription with Mucosta®SR Tab.
• Patients with hypersensitivity to Rebamipide or its component ingredients.
• Patients deemed not suitable for surveillance enrollment according to investigator's medical judgment

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Soon Chun Hyang University Hospital Seoul

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

rebamipide

Central Study Contacts

Jisu Yang

CONTACT

010-3188-9178; js.yang@otsuka.co.kr

Study Design

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

Study Record Dates

• First Submitted: August 24, 2021
• First Posted: September 17, 2021
• Study Start: October 7, 2021
• Primary Completion: December 15, 2024
• Study Completion: December 15, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)