Efficacy of Tegoprazan Based Bismuth Quadruple Therapy for Helicobacter Pylori Infection

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

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)

Study Overview

• Status: Active, not recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Tegoprazan; Drug: Lansoprazole

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 217
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Incheon St. Mary's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: tegoprazan based bismuth quadruple therapy group	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
ACTIVE_COMPARATOR: PPI based bismuth quadruple therapy group	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
H. pylori eradication rate of each group	H. pylori eradication rate of each group	UBT test 4 weeks after completion of eradication treatment

Collaborators and Investigators

• Sponsor: Incheon St.Mary's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2021
• Primary Completion (ANTICIPATED): February 28, 2022
• Study Completion (ANTICIPATED): March 31, 2022

Study Registration Dates

• First Submitted: December 14, 2020
• First Submitted That Met QC Criteria: December 14, 2020
• First Posted (ACTUAL): December 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2022
• Last Update Submitted That Met QC Criteria: January 27, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole
• Other Study ID Numbers: OC20MIDI0057

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No