Clinical trial NCT05048069: Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab.
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'
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Gastritis
Chronic Gastritis
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-09-17
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed 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)

Eligibility criteria: 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

Primary outcomes:
measure: Overall clinical improvement
timeFrame: at 2 weeks of treatment
measure: the incidence rate and the number of cases for adverse events (AEs)
timeFrame: Safety information that occurred from the first administration to 3 days after discontinuation will be collected.
Secondary outcomes:
measure: Endoscopic improvement rate
timeFrame: at baseline and 2 weeks
measure: Gastric symptoms
timeFrame: at baseline and 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Seoul
Study officials:
References: