NCT04674774

Brief 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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
217

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

March 4, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

December 14, 2020

Last Update Submit

January 27, 2022

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

  • H. pylori eradication rate of each group

    H. pylori eradication rate of each group

    UBT test 4 weeks after completion of eradication treatment

Study Arms (2)

tegoprazan based bismuth quadruple therapy group

EXPERIMENTAL

tegoprazan based bismuth quadruple therapy group

Drug: Tegoprazan

PPI based bismuth quadruple therapy group

ACTIVE COMPARATOR

PPI based bismuth quadruple therapy group

Drug: Lansoprazole

Interventions

TegoprazanDRUG

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

tegoprazan based bismuth quadruple therapy group
LansoprazoleDRUG

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

PPI based bismuth quadruple therapy group

Eligibility Criteria

Age19 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients who male or female aged 19 to 75 years old and fall under the following conditions with confirmed helicobacter pylori infection

You may not qualify if:

  • patients who have H.pylori eradication history
  • patients with history of gastric cancer surgery
  • patients who have taken antibiotics within 4 weeks prior to trial
  • a person who taking HIV protease inhibitors (atazanavir, nelfinavir) or a drug containing rilpivirine
  • pregnant or breastfeeding women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Incheon St. Mary's Hospital

Incheon, South Korea

Location

MeSH Terms

Interventions

tegoprazanLansoprazole

Intervention Hierarchy (Ancestors)

2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzimidazolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 14, 2020

First Posted

December 19, 2020

Study Start

March 4, 2021

Primary Completion

February 28, 2022

Study Completion

March 31, 2022

Last Updated

February 10, 2022

Record last verified: 2022-01

Locations

KR(1)