Clinical Trial to Compare 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

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

Study Overview

• Status: Completed
• Conditions: Gastritis
• Intervention / Treatment: Drug: Axid Capsule 150mg; Drug: Mucotra SR Tablet 150mg

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: Interventional
• Enrollment (Actual): 260
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • The Catholic University of Korea c St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Nizatidine Monotherapy	Drug: Axid Capsule 150mg; Nizatidine Monotherapy; Other Names: Axid
Experimental: Rebamipide/Nizatidine Combination Therapy	Drug: Mucotra SR Tablet 150mg; Rebamipide/Nizatidine Combination Therapy; Other Names: Mucotra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Daewoong Pharmaceutical Co. LTD.
• Investigators: Principal Investigator: Myung Kyu Choi, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2021
• Primary Completion (Actual): December 15, 2022
• Study Completion (Actual): December 15, 2022

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 11, 2021

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

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: No
• Studies a U.S. FDA-regulated device product: No