- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05072938
Phase IV Clinical Trial to Compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis
A Multi-center, Open-label, Randomized, Phase IV Clinical Trial to Compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The purpose of this study is to compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy with Nizatidine Monotherapy in Patients with Gastritis.
Anticipated result is to prove superiority of Rebamipide/Nizatidine combination therapy at 2 weeks compared to Nizatidine Monotherapy.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female aged 19 years or older and under 75 years
- 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)
- 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
- Subject who is unable to examine the upper gastrointestinal endoscope
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
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
- A person who needs to administer a taboo drug during the clinical trial period.
- Pregnant women and nursing women
- 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.
- Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
- Severe liver disorder (AST or ALT > 3 times the normal upper limit of the organ)
- Serious nephropathy (creatinine clearance < 50 mL/min)
- Subject who has been administered (applied) other clinical medications or medical devices within 4 weeks of screening
- Subject who the investigator determined it is inappropriate to participate in this clinical trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Nizatidine Monotherapy
|
Nizatidine Monotherapy
Other Names:
|
Experimental: Rebamipide/Nizatidine Combination Therapy
|
Rebamipide/Nizatidine Combination Therapy
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy at 2 weeks from baseline
Time Frame: At 2 weeks
|
Pearson's chi-square test or Fisher's exact test will be used to compare the effective rate between two groups
|
At 2 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Gastritis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Gastrointestinal Agents
- Anti-Ulcer Agents
- Histamine Antagonists
- Histamine Agents
- Histamine H2 Antagonists
- Nizatidine
Other Study ID Numbers
- MUC0S-P401
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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