Monitoring the safety and effectiveness of Mucosta®SR Tablets in patients with gastritis
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'
This study is testing how safe and effective Mucosta®SR Tablets are for people with gastritis over a two-week period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Korea Otsuka Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05048069 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and effectiveness of Mucosta®SR Tablets (Rebamipide) in patients diagnosed with acute or chronic gastritis. Conducted in accordance with South Korean regulations, the study involves a single-arm, multi-center approach where patients will be observed for two weeks after starting treatment. Participation is voluntary, and follow-up is recommended but not mandatory, allowing for flexibility based on the investigator's judgment. The study collects real-world data on the drug's performance in a practical medical environment.
Who should consider this trial
Good fit: Ideal candidates include adult patients with gastric mucosal lesions related to acute or chronic gastritis who are prescribed Mucosta®SR Tablets.
Not a fit: Patients with a prior history of Mucosta®SR Tablet prescription or those with hypersensitivity to its components may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of Mucosta®SR Tablets for patients suffering from gastritis.
How similar studies have performed: While this study follows established protocols for post-marketing surveillance, similar approaches have been utilized in other contexts, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul
- Soon Chun Hyang University Hospital Seoul — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Jisu Yang
- Email: js.yang@otsuka.co.kr
- Phone: 010-3188-9178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.