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The purpose of this study is to compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy with Nizatidine Monotherapy in Patients with Gastritis
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nizatidine Monotherapy | Active Comparator | Nizatidine Monotherapy |
|
| Rebamipide/Nizatidine Combination Therapy | Experimental | Rebamipide/Nizatidine Combination Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mucotra SR Tablet 150mg | Drug | Rebamipide/Nizatidine Combination Therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy | Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy at 2 weeks compated to baseline | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Erosion cure rate on upper gastrointestinal endoscopy | Erosion cure rate on upper gastrointestinal endoscopy at 2 weeks compared to baseline | 2 weeks |
| Effective rate of bleeding on upper gastrointestinal endoscopy |
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Inclusion Criteria:
Exclusion Criteria
Subject who is unable to examine the upper gastrointestinal endoscope
A person with the following past history
A person accompanied by the following diseases
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.
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| Name | Affiliation | Role |
|---|---|---|
| Myung Kyu Choi | The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea c St. Mary's Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D005756 | Gastritis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D013272 | Stomach Diseases |
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| ID | Term |
|---|---|
| D016567 | Nizatidine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Axid Capsule 150mg | Drug | Nizatidine Monotherapy |
|
|
Effective rate of bleeding on upper gastrointestinal endoscopy at 2 weeks compared to baseline
| 2 weeks |
| Effective rate of flares on upper gastrointestinal endoscopy | Effective rate of flares on upper gastrointestinal endoscopy at 2 weeks compared to baseline | 2 weeks |
| Edema cure rate on upper gastrointestinal endoscopy | Edema cure rate on upper gastrointestinal endoscopy at 2 weeks compared to baseline | 2 weeks |
| Validity rate of subjective symptom scores evaluated by subjects | Validity rate of subjective symptom scores evaluated by subjects at 2 weeks compared to baseline | 2 weeks |
| Change in total subjective symptom score and individual symptom score assessed by the subject at 2 weeks compared to baseline | Change in total subjective symptom score and individual symptom score assessed by the subject | 2 weeks |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |