Clinical Trial to Compare Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis

Daewoong Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Gastritis

Treatments: Drug: Mucotra SR Tablet 150mg; Drug: Axid Capsule 150mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT05072938

MUC0S-P401

Details and patient eligibility

About

The purpose of this study is to compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy with Nizatidine Monotherapy in Patients with Gastritis

Full 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.

Enrollment: 260 patients

Sex: All

Ages: 19 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Male or female aged 19 years or older and under 75 years
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

1. Subject who is unable to examine the upper gastrointestinal endoscope

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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260 participants in 2 patient groups

Nizatidine Monotherapy

Active Comparator group

Description:

Nizatidine Monotherapy

Treatment:

Drug: Axid Capsule 150mg

Rebamipide/Nizatidine Combination Therapy

Experimental group

Description:

Rebamipide/Nizatidine Combination Therapy

Treatment:

Drug: Mucotra SR Tablet 150mg