NCT05072938

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 11, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2022

Completed
Last Updated

July 1, 2024

Status Verified

June 1, 2024

Enrollment Period

1.2 years

First QC Date

August 13, 2021

Last Update Submit

June 27, 2024

Conditions

Gastritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Erosion cure rate on upper gastrointestinal endoscopy

    2 weeks

  • Effective rate of bleeding on upper gastrointestinal endoscopy

    2 weeks

  • Effective rate of flares on upper gastrointestinal endoscopy

    2 weeks

  • Edema cure rate on upper gastrointestinal endoscopy

    2 weeks

  • Validity rate of subjective symptom scores evaluated by subjects

    2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Nizatidine Monotherapy

ACTIVE COMPARATOR

Nizatidine Monotherapy

Drug: Axid Capsule 150mg

Rebamipide/Nizatidine Combination Therapy

EXPERIMENTAL

Rebamipide/Nizatidine Combination Therapy

Drug: Mucotra SR Tablet 150mg

Interventions

Mucotra SR Tablet 150mgDRUG

Rebamipide/Nizatidine Combination Therapy

Also known as: Mucotra
Rebamipide/Nizatidine Combination Therapy
Axid Capsule 150mgDRUG

Nizatidine Monotherapy

Also known as: Axid
Nizatidine Monotherapy

Eligibility Criteria

Age19 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged 19 years or older and under 75 years
  • 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)
  • Subject who voluntarily decides to participate in the trial after hearing the explanation of this clinical trial and signs the informed consent form.

You may not qualify if:

  • Subject who is unable to examine the upper gastrointestinal endoscope
  • 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
  • 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
  • A person who needs to administer a taboo drug during the clinical trial period.
  • Pregnant women and nursing women
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Catholic University of Korea c St. Mary's Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Gastritis

Interventions

Nizatidine

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Myung Kyu Choi

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2021

First Posted

October 11, 2021

Study Start

September 30, 2021

Primary Completion

December 15, 2022

Study Completion

December 15, 2022

Last Updated

July 1, 2024

Record last verified: 2024-06

Locations

KR(1)