Tegoprazan-containing Sequential for H. Pylori

NCT06382493 | Recruiting DMC

• 1 other identifier: B-2011-648-005
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Eradication rate

  Efficacy of H. pylori eradication therapy. confirmed by negative UBT test

  2 or 3 month

Secondary Outcomes (1)

• Adverse events

  up to 6 month

Study Arms (2)

Esomeprazole-containing sequential H. pylori eradication therapy (conventional method)

ACTIVE COMPARATOR

esomeprazole (40 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then esomeprazole (40 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days.

Drug: Esomeprazole-containing sequential H. pylori eradication therapy

Tegoprazan-containing sequential H. pylori eradication therapy (experimental method)

EXPERIMENTAL

tegoprazan (50 mg) plus amoxicillin (1000 mg) twice a day for initial 5 days, and then tegoprazan (50 mg) with clarithromycin (500 mg) and metronidazole (500 mg) twice a day for the remaining 5 days.

Drug: Tegoprazan-containing sequential H. pylori eradication therapy

Interventions

Tegoprazan-containing sequential H. pylori eradication therapy DRUG

tegoprazan was administered, instead propton-pump inhibitor, as acid blockade in H. pylori eradication sequential therapy

Tegoprazan-containing sequential H. pylori eradication therapy (experimental method)

Esomeprazole-containing sequential H. pylori eradication therapy DRUG

Esomeprazole was administered as acid blockade in H. pylori eradication sequential therapy (conventional acid blockade method for sequential eradication therapy)

Esomeprazole-containing sequential H. pylori eradication therapy (conventional method)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

RECRUITING

Related Publications (1)

• Lee JW, Kim N, Lee J, Jo SY, Lee DH. Efficacy of Tegoprazan-Containing Sequential Eradication Treatment Compared to Esomeprazole-Containing Sequential Eradication of Helicobacter pylori in South Korea, a Region With High Antimicrobial Resistance: A Prospective, Randomized, Single Tertiary Center Study. Helicobacter. 2024 Sep-Oct;29(5):e13143. doi: 10.1111/hel.13143.

  PMID: 39434634 DERIVED

Study Officials

• Nayoung Kim, Prof.

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jungwon Lee, Dr.

CONTACT

821093567758; saludos@naver.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 20, 2024
• First Posted: April 24, 2024
• Study Start: February 1, 2021
• Primary Completion (Estimated): December 12, 2026
• Study Completion (Estimated): December 12, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)