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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005723

Enrollment

216

Registered

2020-12-30

Start date

2020-12-28

Completion date

Unknown

Last updated

2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : oral administration of tegoprazan-based bismuth quadruple therapy(tegoprazan, bismuth, metronidazole, tetracycline) with bismuth based quadruple therapy(PPI, bismuth, metronidazole, tetracyclin

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
H. pylori eradication rate of each group	—

Secondary

Measure	Time frame
Drug compliance	—

Countries

Korea, Republic of

Contacts

Public ContactJoonsung Kim

The Catholic University of Korea, Incheon St. Mary's Hospital

kijoons@hanmail.net+82-32-280-5056

Outcome results