Efficacy comparison of 7 and 14-days P-CAB based bismuth-containing quadruple regimen with PPI based bismuth-containing quadruple regimen for Helicobacter pylori infection: open-label, randomized controlled trial
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0007444
- Lead Sponsor
- Hallym University Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 366
1) age >19 or <85 years
2) patients who tested positive for H. pylori
3) patients who had endoscopically confirmed gastric ulcer, duodenal ulcer (including scar), low grade gastric MALT lymphoma, gastric dysplasia or early gastric cancer, Atrophic gastritis, H. pylori gastritis
4) patients who will be compliant to study procedures
5) patients who have signed the Informed Consent
6) patients who have agreed to use acceptable contraception methods
1) previous H. pylori eradication therapy
2) patients with severe concurrent disease or malignancy
3) history of gastrectomy
4) patients who used PPI, H2 blocker, Histamine H2-receptor antagonists 14 days prior to trial
5) patients who have taken bismuth-containing drugs or antibiotics within 28 days prior to trial
6) pregnant or lactating women
7) liver cirrhosis or Hepatic insufficiency
8) renal insufficiency
9) other organ cancer within 5 years
10) history of stomach operation
11) addiction to alcohol or illicit and recreational drugs
12) a person who taking HIV protease inhibitors (atazanavir, nelfinavir) or a drug containing rilpivirine
13) patients receiving statin therapy
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method H. pylori eradication rate
- Secondary Outcome Measures
Name Time Method drug compliance