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

Phase 4

Completed

• Conditions: Gastritis
• Interventions: Drug: Axid Capsule 150mg; Drug: Mucotra SR Tablet 150mg

• Registration Number: NCT05072938
• Lead Sponsor: Daewoong Pharmaceutical Co. LTD.

Brief 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

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 Timeline

• Study First Submitted: 2021-08-13
• Study Start: 2021-09-30
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-11
• Primary Completion: 2022-12-15
• Study Completion: 2022-12-15
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 260

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nizatidine Monotherapy	Axid Capsule 150mg	Nizatidine Monotherapy
Rebamipide/Nizatidine Combination Therapy	Mucotra SR Tablet 150mg	Rebamipide/Nizatidine Combination Therapy

Primary Outcome Measures

Name	Time	Method
Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy	2 weeks	Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy at 2 weeks compated to baseline

Secondary Outcome Measures

Name	Time	Method
Effective rate of flares on upper gastrointestinal endoscopy	2 weeks	Effective rate of flares on upper gastrointestinal endoscopy at 2 weeks compared to baseline
Validity rate of subjective symptom scores evaluated by subjects	2 weeks	Validity rate of subjective symptom scores evaluated by subjects at 2 weeks compared to baseline
Erosion cure rate on upper gastrointestinal endoscopy	2 weeks	Erosion cure rate on upper gastrointestinal endoscopy at 2 weeks compared to baseline
Effective rate of bleeding on upper gastrointestinal endoscopy	2 weeks	Effective rate of bleeding on upper gastrointestinal endoscopy at 2 weeks compared to baseline
Edema cure rate on upper gastrointestinal endoscopy	2 weeks	Edema cure rate on upper gastrointestinal endoscopy at 2 weeks compared to baseline
Change in total subjective symptom score and individual symptom score assessed by the subject at 2 weeks compared to baseline	2 weeks	Change in total subjective symptom score and individual symptom score assessed by the subject

Trial Locations

Locations (1)

The Catholic University of Korea c St. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of