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

Last updated: September 26, 2023
Sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Bowel Dysfunction

Ulcers

Stomach Discomfort

Treatment

Mucosta®SR Tablets 150mg(Rebamipide)

Clinical Study ID

NCT05048069
037-402-00047
  • Ages > 19
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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'smedical judgment

Study Design

Total Participants: 600
Treatment Group(s): 1
Primary Treatment: Mucosta®SR Tablets 150mg(Rebamipide)
Phase:
Study Start date:
October 07, 2021
Estimated Completion Date:
December 15, 2024

Study 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)

Connect with a study center

  • Soon Chun Hyang University Hospital Seoul

    Seoul,
    Korea, Republic of

    Active - Recruiting

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