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Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

Primary Purpose

Helicobacter Pylori Infection

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Tegoprazan
Lansoprazole
Sponsored by
Incheon St.Mary's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection

Eligibility Criteria

19 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Incheon St. Mary's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

tegoprazan based bismuth quadruple therapy group

PPI based bismuth quadruple therapy group

Arm Description

tegoprazan based bismuth quadruple therapy group

PPI based bismuth quadruple therapy group

Outcomes

Primary Outcome Measures

H. pylori eradication rate of each group
H. pylori eradication rate of each group

Secondary Outcome Measures

Full Information

First Posted
December 14, 2020
Last Updated
January 27, 2022
Sponsor
Incheon St.Mary's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04674774
Brief Title
Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection
Official Title
Efficacy of Tegoprazan Based Bismuth Quadruple Therapy Compared With Bismuth Quadruple Therapy for Helicobacter Pylori Infection: Randomized, Double-blind, Active-Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 4, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Incheon St.Mary's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tegoprazan based bismuth quadruple therapy group
Arm Type
Experimental
Arm Description
tegoprazan based bismuth quadruple therapy group
Arm Title
PPI based bismuth quadruple therapy group
Arm Type
Active Comparator
Arm Description
PPI based bismuth quadruple therapy group
Intervention Type
Drug
Intervention Name(s)
Tegoprazan
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Lansoprazole
Intervention Description
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
Primary Outcome Measure Information:
Title
H. pylori eradication rate of each group
Description
H. pylori eradication rate of each group
Time Frame
UBT test 4 weeks after completion of eradication treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Incheon St. Mary's Hospital
City
Incheon
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

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