Clinical trial NCT05072938: Clinical Trial to Compare Rebamipide/Nizatidine Combination Therapy With Nizatidine Monotherapy in Patients With Gastritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastritis
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2021-10-11
Enrollment: 260
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy
timeFrame: 2 weeks
Secondary outcomes:
measure: Erosion cure rate on upper gastrointestinal endoscopy
timeFrame: 2 weeks
measure: Effective rate of bleeding on upper gastrointestinal endoscopy
timeFrame: 2 weeks
measure: Effective rate of flares on upper gastrointestinal endoscopy
timeFrame: 2 weeks
measure: Edema cure rate on upper gastrointestinal endoscopy
timeFrame: 2 weeks
measure: Validity rate of subjective symptom scores evaluated by subjects
timeFrame: 2 weeks
measure: Change in total subjective symptom score and individual symptom score assessed by the subject at 2 weeks compared to baseline
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea c St. Mary's Hospital
Study officials:
affiliation: The Catholic University of Korea
name: Myung Kyu Choi
role: PRINCIPAL_INVESTIGATOR
References: