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NCT04674774 Clinical Trial

Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Official title:
Efficacy of Tegoprazan Based Bismuth Quadruple Therapy Compared With Bismuth Quadruple Therapy for Helicobacter Pylori Infection: Randomized, Double-blind, Active-Controlled Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04674774
Other study ID # OC20MIDI0057
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date March 4, 2021
Est. completion date March 31, 2022

Study information
Verified date January 2022
Source Incheon St.Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to investigate eradication rate, drug compliance, and adverse events in patients with confirmed Helicobacter pylori infection between tegoprazan, bismuth, metronidazole, and tetracycline for 14 days (TBMT) and PPI, bismuth, metronidazole, and tetracycline for 14 days (LBMT)

Description:

This is a multi-center, double-blind, randomized, active-controlled study.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 217
Est. completion date March 31, 2022
Est. primary completion date February 28, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years to 75 Years
Eligibility Inclusion Criteria: patients who male or female aged 19 to 75 years old and fall under the following conditions with confirmed helicobacter pylori infection Exclusion Criteria: 1. patients who have H.pylori eradication history 2. patients with history of gastric cancer surgery 3. patients who have taken antibiotics within 4 weeks prior to trial 4. a person who taking HIV protease inhibitors (atazanavir, nelfinavir) or a drug containing rilpivirine 5. pregnant or breastfeeding women

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tegoprazan
oral administration of tegoprazan-based bismuth quadruple therapy(tegoprazan 50 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 days
• Lansoprazole
oral administration of PPI-based bismuth quadruple therapy(lansoprazole 30 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 day

Locations
Country Name City State
Korea, Republic of Incheon St. Mary's Hospital Incheon

Sponsors (1)
Lead Sponsor Collaborator
Incheon St.Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary H. pylori eradication rate of each group H. pylori eradication rate of each group UBT test 4 weeks after completion of eradication treatment
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