Skip to main content
OpenTrials
Completed

NCT Number: NCT05072938

Clinical Trial to Compare 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

Completed

Looking for future studies?

Notify Me

Key information

Age range

19 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Seoul, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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.
  • Subject with genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption, etc.
  • Severe liver disorder (AST or ALT > 3 times the normal upper limit of the organ)
  • Serious nephropathy (creatinine clearance < 50 mL/min)
  • Subject who has been administered (applied) other clinical medications or medical devices within 4 weeks of screening
  • Subject who the investigator determined it is inappropriate to participate in this clinical trial.

Treatment and study plan

Mucotra SR Tablet 150mg

Drug

Rebamipide/Nizatidine Combination Therapy

Other names: Mucotra

Axid Capsule 150mg

Drug

Nizatidine Monotherapy

Other names: Axid

Primary outcomes

  1. 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

Secondary outcomes

  1. 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. 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

  3. 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

  4. Edema cure rate on upper gastrointestinal endoscopy

    Time frame: 2 weeks

    Edema cure rate on upper gastrointestinal endoscopy at 2 weeks compared to baseline

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 11, 2021
Registry last updated
Jul 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.