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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-10-07

Study Completion Date

2024-12-15

Brief Summary

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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.

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Detailed Description

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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)

Conditions

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Acute Gastritis Chronic Gastritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No