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

June 27, 2024 updated by: Daewoong Pharmaceutical Co. LTD.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy
Time Frame: 2 weeks
Effective rate of gastric mucosal erosion on the upper gastrointestinal endoscopy at 2 weeks compated to baseline
2 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Erosion cure rate on upper gastrointestinal endoscopy
Time Frame: 2 weeks
Erosion cure rate on upper gastrointestinal endoscopy at 2 weeks compared to baseline
2 weeks
Effective rate of bleeding on upper gastrointestinal endoscopy
Time Frame: 2 weeks
Effective rate of bleeding on upper gastrointestinal endoscopy at 2 weeks compared to baseline
2 weeks
Effective rate of flares on upper gastrointestinal endoscopy
Time Frame: 2 weeks
Effective rate of flares on upper gastrointestinal endoscopy at 2 weeks compared to baseline
2 weeks
Edema cure rate on upper gastrointestinal endoscopy
Time Frame: 2 weeks
Edema cure rate on upper gastrointestinal endoscopy at 2 weeks compared to baseline
2 weeks
Validity rate of subjective symptom scores evaluated by subjects
Time Frame: 2 weeks
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
Time Frame: 2 weeks
Change in total subjective symptom score and individual symptom score assessed by the subject
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daewoong Pharmaceutical Co. LTD.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Myung Kyu Choi, The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 1, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings