Phase IV Clinical Trial to Compare the Efficacy and Safety of Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis

Gastritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05072938
• Other study ID #: MUC0S-P401
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: November 2021
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: Daewoong Pharmaceutical Co. LTD.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: December 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 74 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gastritis

Intervention

Drug:
• Mucotra SR Tablet 150mg
Rebamipide/Nizatidine Combination Therapy
• Axid Capsule 150mg
Nizatidine Monotherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewoong Pharmaceutical Co. LTD.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy at 2 weeks from baseline	Pearson's chi-square test or Fisher's exact test will be used to compare the effective rate between two groups	At 2 weeks