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

Sponsor
Daewoong Pharmaceutical Co. LTD. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05072938
Collaborator
(none)
260
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Mucotra SR Tablet 150mg
  • Drug: Axid Capsule 150mg
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
260 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Nizatidine Monotherapy

Nizatidine Monotherapy

Drug: Axid Capsule 150mg
Nizatidine Monotherapy
Other Names:
  • Axid

    		•
    Experimental: Rebamipide/Nizatidine Combination Therapy

    Rebamipide/Nizatidine Combination Therapy

    Drug: Mucotra SR Tablet 150mg
    Rebamipide/Nizatidine Combination Therapy
    Other Names:
  • Mucotra

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy at 2 weeks from baseline [At 2 weeks]

      Pearson's chi-square test or Fisher's exact test will be used to compare the effective rate between two groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 74 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    1. 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

    1. A person who needs to administer a taboo drug during the clinical trial period.

    2. Pregnant women and nursing women

    3. 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.

    4. Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.

    5. Severe liver disorder (AST or ALT > 3 times the normal upper limit of the organ)

    6. Serious nephropathy (creatinine clearance < 50 mL/min)

    7. Subject who has been administered (applied) other clinical medications or medical devices within 4 weeks of screening

    8. Subject who the investigator determined it is inappropriate to participate in this clinical trial.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Daewoong Pharmaceutical Co. LTD.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daewoong Pharmaceutical Co. LTD.
    ClinicalTrials.gov Identifier:
    NCT05072938
    Other Study ID Numbers:
    • MUC0S-P401
    First Posted:
    Oct 11, 2021
    Last Update Posted:
    Oct 11, 2021
    Last Verified:
    Aug 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Gastritis
    Nizatidine

    Study Results

    No Results Posted as of Oct 11, 2021