Tegoprazan-containing Sequential for H. Pylori

Helicobacter Pylori Infection Clinical Trial

Official title:

Efficacy of Tegoprazan-containing Sequential Therapy Compared to Proton Pump Inhibitor-based Eradication in South Korea, a Region With High Antimicrobial Resistance: A Prospective Randomized Single Tertiary Center Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06382493
• Other study ID #: B-2011-648-005
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 12, 2024

Study information

• Verified date: April 2024
• Source: Seoul National University Bundang Hospital
• Contact: Jungwon Lee, Dr.
• Phone: 821093567758
• Email: saludos[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

As H. pylori eradication, the investigators prepared a randomized controlled clinical trial whether tegoprazan-containing 10-day sequential treatment was effective compared to conventional PPI-containing 10-day sequential eradication therapy

Description:

Eradication treatment containing potassium-competitive acid blocker has shown acceptable eradication efficacy. In regions such as Korea, where the prevalence of antimicrobial resistance is high, alternative combinations of antibiotics such as sequential or concomitant therapy are needed. This study compared the outcome of sequential therapy containing tegoprazan, a new potassium-competitive acid blocker, with the conventional esomeprazole-containing sequential therapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 12, 2024
• Est. primary completion date: December 12, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Patients who had H. pylori infection proved by positive test result of urea breath test (UBT), rapid urase test or pathologic examination (warthin-giemsa staining)

Exclusion Criteria:

• congestive heart failure, NYHA III or IV
• end-stage renal disease
• alcoholics
• drug abusers
• pregnant or nursing women

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

Drug:
• Tegoprazan-containing sequential H. pylori eradication therapy
tegoprazan was administered, instead propton-pump inhibitor, as acid blockade in H. pylori eradication sequential therapy
• Esomeprazole-containing sequential H. pylori eradication therapy
Esomeprazole was administered as acid blockade in H. pylori eradication sequential therapy (conventional acid blockade method for sequential eradication therapy)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate	Efficacy of H. pylori eradication therapy. confirmed by negative UBT test	2 or 3 month
Secondary	Adverse events	any adverse events occured during or after intervention (eradication therapy)	up to 6 month