Clinical Trial to Compare Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis
NCT ID: NCT05072938
Last Updated: 2024-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
260 participants
INTERVENTIONAL
2021-09-30
2022-12-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Post-Marketing Surveillance of Safety and Effectiveness of Mucosta®SR Tab.
NCT05048069
A Study to Evaluate the Efficacy and Safety of DA-6034 and to Demonstrate the Non-inferiority of DA-6034
NCT01813812
Anti Free Radical & Anti Inflammatory Effect & Safety of Rebamipide in Chronic Gastritis
NCT00996788
Gastrointestinal Integrity After Naproxen + Rebamipide Versus Naproxen + Placebo
NCT02632812
Rebamipide in Combination With Esomeprazole in the Management of Asian Patients With Functional Dyspepsia
NCT02134405
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Anticipated result is to prove superiority of Rebamipide/Nizatidine combination therapy at 2 weeks compared to Nizatidine Monotherapy.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Nizatidine Monotherapy
Nizatidine Monotherapy
Axid Capsule 150mg
Nizatidine Monotherapy
Rebamipide/Nizatidine Combination Therapy
Rebamipide/Nizatidine Combination Therapy
Mucotra SR Tablet 150mg
Rebamipide/Nizatidine Combination Therapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mucotra SR Tablet 150mg
Rebamipide/Nizatidine Combination Therapy
Axid Capsule 150mg
Nizatidine Monotherapy
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Subject who was diagnosed with acute or chronic gastritis in upper gastrointestinal endoscopy conducted within 7 days prior to the start of administration of medications for clinical trials and identified at least one labyrinth (defect of mucosal surface layer)
3. Subject who voluntarily decides to participate in the trial after hearing the explanation of this clinical trial and signs the informed consent form.
Exclusion Criteria
2. A person with the following past history
* Surgery to suppress gastric acid secretion or gastrointestinal and esophagus surgery
* Malignant tumor of the digestive system
* overreacted to the components of medicine for clinical trials and H2 receptor blockers
* Drug or alcohol abuse
3. A person accompanied by the following diseases
* Digestive ulcers (excluding half a scar)
* Reflux esophagitis
* Inflammatory bowel disease (cron disease, ulcerative colitis)
* Thrombotic diseases (such as cerebral thrombosis, myocardial infarction, thrombotic venous inflammation, etc.)
* Zollinger-Ellison syndrome
* Subject with mental illness, cardiovascular system, respiratory system, endocrine system, central nervous system who the investigator determined that it is difficult to participate in this clinical trial
4. A person who needs to administer a taboo drug during the clinical trial period.
5. Pregnant women and nursing women
6. Fertilized women and men who have a pregnancy plan or do not have the will to use the appropriate contraceptive method during the clinical trial period.
7. Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
8. Severe liver disorder (AST or ALT \> 3 times the normal upper limit of the organ)
9. Serious nephropathy (creatinine clearance \< 50 mL/min)
10. Subject who has been administered (applied) other clinical medications or medical devices within 4 weeks of screening
11. Subject who the investigator determined it is inappropriate to participate in this clinical trial.
19 Years
74 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Daewoong Pharmaceutical Co. LTD.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Myung Kyu Choi
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Catholic University of Korea c St. Mary's Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MUC0S-P401
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.