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

Chronic Gastritis Clinical Trial

— MCTSRPMS  

Official title:

Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab. in Korean Patients With Acute or Chronic Gastritis in Accordance With Korean Regulation, 'Standard for Re-examination of New Drugs'

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05048069
• Other study ID #: 037-402-00047
• Status: Recruiting
• Start date: October 7, 2021
• Est. completion date: December 15, 2024

Study information

• Verified date: September 2023
• Source: Korea Otsuka Pharmaceutical Co., Ltd.
• Contact: Jisu Yang
• Phone: 010-3188-9178
• Email: js.yang[@]otsuka.co.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

According to the "Standards for Re-examination of New Drugs, etc." of South Korea, this PMS is conducted in order to collect safety and efficacy information for patients prescribed with Mucosta®SR Tab. under actual conditions of treatment during the re-examination period of Mucosta®SR Tab. 150mg (Rebamipide)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 15, 2024
• Est. primary completion date: December 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Adult patients with gastric mucosal lesions (erosion, bleeding, redness, and edema) in acute gastritis or acute exacerbation of chronic gastritis.

2. Patients prescribed with Mucosta®SR Tab. according to the medical considerations of the investigator.

3. 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.

Exclusion Criteria:

1. Patients with prior history of prescription with Mucosta®SR Tab.

2. Patients with hypersensitivity to Rebamipide or its component ingredients.

3. Patients deemed not suitable for surveillance enrollment according to investigator's medical judgment

Related Conditions & MeSH terms

• Acute Gastritis
• Chronic Gastritis
• Gastritis

Intervention

Drug:
• Mucosta®SR Tablets 150mg(Rebamipide)
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.

Locations

Country	Name	City	State
Korea, Republic of	Soon Chun Hyang University Hospital Seoul	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Endoscopic improvement rate	If upper GI endoscopy is performed at baseline and follow-up visits, the erosion score will be assessed and endoscopic improvement rate at 2 weeks will be evaluated. Endoscopic improvement rate is defined as =50% reduction of the erosion score.	at baseline and 2 weeks
Secondary	Gastric symptoms	Presence and type of gastric symptoms at baseline and 2 weeks will be collected.	at baseline and 2 weeks