Efficacy and safety of Fexuprazan based Helicobacter pylori eradication therapy

Not Applicable

• Conditions: Diseases of the digestive system

• Registration Number: KCT0008592
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 August 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. Male or female between the ages of 20 and 80
2. A person diagnosed as positive for Helicobacter pylori in one of the urea breath test, rapid urease test, and biopsy
3. Patients with a history of atrophic gastritis, peptic ulcer, low-grade MALT lymphoma, functional dyspepsia, idiopathic thrombocytopenic purpura, iron-deficiency anemia, hyperproliferative polyp, past history of endoscopic resection for gastric cancer or gastric adenoma, or family history of gastric cancer
4. A person who agrees to participate in this test and voluntarily signs a written consent form

Exclusion Criteria

1. Those who have undergone Helicobacter pylori eradication therapy prior to participation in the study
2. Those who have a history of hypersensitivity to the active ingredient or excipient of this clinical trial drug or penicillin-based antibiotics or macrolide-based antibiotics
3. Those who are taking contraindications to this clinical trial drug or concomitant drug
4. Proton pump inhibitors, histamine receptor antagonists, or potassium competitive gastric acid secretion inhibitors were taken for 2 weeks before the start of study drug administration, or proton pump inhibitors, histamine receptor antagonists, or potassium competitive gastric acid secretion inhibitors other than test drugs were taken until the end of the study participation period after randomization. Those who need to take
5. Those who have taken antibiotics or Bismuth within 4 weeks before upper gastrointestinal endoscopy and urea breath test, or who need to take antibiotics or Bismuth within 4 weeks before randomization and until the end of the study participation period after randomization
6. Patients with renal or hepatic impairment who show the following abnormal values ??in blood chemistry tests
- AST, ALT, ALP, ?-GT, and total bilirubin levels are more than twice the upper limit reference value (UNL) for each test institution
- BUN, creatinine levels are more than 1.5 times the upper limit reference value (UNL) for each test institution
7. Patients with central nervous system infection, electrolyte disorders (hypokalemia, hypomagnesemia)
8. In case of showing abnormal ECG results such as QT interval prolongation in screening ECG
9. Gastrointestinal bleeding during upper gastrointestinal endoscopy
10. Those with uncontrolled diabetes, high blood pressure, or liver dysfunction
11. A person with a history of malignant tumor of the digestive system within 5 years (except after endoscopic resection of gastric adenoma or early gastric cancer)
12. Those who have had esophageal or gastric resection
13. Subjects with genetic diseases such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
14. Alcoholics Anonymous
15. Those who do not agree to use the following appropriate methods of contraception for themselves or their partners during the clinical trial period
? Surgical infertility conditions: tubal ligation/tubectomy, hysterectomy, vasectomy/tubectomy, etc.
? Intrauterine device or intrauterine system
? Hormonal contraceptives: oral progesterone single or estrogen-progesterone combination, transdermal delivery contraceptives, depot injections, etc.
? Barrier method: Using a combination of male physical barrier methods (eg male condoms) and female physical barrier methods (eg female condoms, cervical cap, diaphragm, contraceptive sponge) together with spermicide Use (However, it is not recommended for both men and women to use condoms as they may be less effective than expected contraception due to damage caused by physical friction)
However, women who are medically unable to conceive can participate in this clinical trial: women who have undergone menopause (24 months or more of amenorrhea), hysterectomy, salpingectomy, bilateral oophorectomy, etc.
16. Pregnant and lactating women
17. Persons judged by other researchers to be inappropriate to participate in clinical trials

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eradication rate

Secondary Outcome Measures

Name	Time	Method
medication adherence