Efficacy of tegoprazan based bismuth quadruple therapy compared with bismuth quadruple therapy for Helicobacter pylori infection: Randomized, Double-blind, Active-Controlled Study

Not Applicable

Completed

• Conditions: Certain infectious and parasitic diseases

• Registration Number: KCT0005723
• Lead Sponsor: The Catholic University of Korea, Incheon St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-10-11
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 216

Inclusion Criteria

patients who male or female aged 19 to 75 years old and fall under the following conditions with confirmed helicobacter pylori infection
- helicobacter gastrits, atrophic gastritis, family history of gastric cancer
- peptic ulcer
- gastric MATL lymphoma(Extraodal marginal zone B cell lymphoma of MALT)
- patients diagnosed with early gastric cancer or gastric adenoma and underwent endoscopic submucosal dissection (ESD)

Exclusion Criteria

1. patients who have H.pylori eradication history
2. patients with history of gastric cancer surgery
3. patients with history of gastrointestinal malignancy within 5 years(gastric cancer excluded)
4. pateints with severe liver failure
5. patients with hematologic disorders or history
6. patients with central nervous system infection or organic neurological disorders(including hypothyroidism, hypoadreno corticism)
7. patients with infectious mononucleosis
8. patients with renal disorder or renal failure
9. patients who have taken antibiotics within 4 weeks prior to trial
10. patients who have a history or hypersensitivity reaction(hypersensitivity reactions of anaphylaxis, anaphylaxis shock, angioedema, bronchospasm, acute tubulo-interstitial nephritis and allergy) to investigational products(tegoprazan, benzimidazole, penicillin, macrolide, imidazole derivatives, tetracycline)
11. a person who taking terfenadine,cisapride, pimozide, astemizole
12. a person who taking HIV protease inhibitors (atazanavir, nelfinavir) or a drug containing rilpivirine
13. patients who are taking contraindicated drugs(Indinavir, Ritonavir, Cyclosporin, Terfenadine, cisapride, Pimozide, Astemizole, HIV protease inhibitors(Atazanavir, Nelfinavir) Ergot alkaloids and derivatives(Ergotamine, Dihydroergotamine), Mizolastine, Bepridil, Ticagrelor, Retinoids (isotretinoin and etcs)
14. patients with ongoing alcohol metabolism(who have taken disulfiram within 2 weeks prior to trial)
15. pregnant or breastfeeding women
16. patients with genetic problems such as galactose intolerance and Lapp lactose deficiency or glucose-galactose uptake, QT prolongation or ventricular arrhythmia(including Torsades de pointes) history
17. patients who showed following abnormal laboratory results
- That exceeds 2-fold increase in the upper normal limit of AST, ALT, ALP, ?-GT, or total bilirubin
- That exceeds 1.5-fold increase in the upper normal limit of BUN, Cr

Study & Design

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

Primary Outcome Measures

Name	Time	Method
H. pylori eradication rate of each group

Secondary Outcome Measures

Name	Time	Method
Drug compliance