Trials Sponsors Conditions Drugs Pricing

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pyloriEradication

Outcome Measures

Primary Outcomes (1)

Percentage of Helicobacter Pylori Positive (HP+) Participants With Successful HP Eradication at Week 4 Post- Treatment
HP infection status will be determined by \^13C Urea Breath Test (\^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory.
Week 4-8 post-treatment

Study Arms (3)

Tegoprazan 50mg QD

EXPERIMENTAL

Tegoprazan 50 mg once daily plus Amoxicillin 1000mg TID for up to 2 weeks

Drug: Tegoprazan 50 mg, tablets, orally, qdDrug: amoxicillin 1000mg tid

Esomeprazole 20 mg BID

ACTIVE COMPARATOR

esomeprazole 20 mg, tablets, orally, bid given in combination with amoxicillin 1000mg，clarithromycin 500mg bid，colloidal bismuth pectin 200mg bid for up to 2 weeks. OR esomeprazole 20 mg, tablets, orally, bis in die given in combination with amoxicillin 750mg capsules, orally, quarter die for up to 2 weeks.

Drug: Esomeprazole 20mg BIDDrug: amoxicillin +clarithromycin+colloidal bismuth pectin BID

Tegoprazan 50 mg BID

Interventions

Tegoprazan 50 mg, tablets, orally, qdDrug

Tegoprazan 50 mg, tablets, orally, qd given in combination with amoxicillin 1000mg capsules, orally, tid for up to 2 weeks.

Tegoprazan 50mg QD

Esomeprazole 20mg BIDDrug

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
amoxicillin +clarithromycin+colloidal bismuth pectin BID
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 75 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients aged ≥18 years with Hp-positive first sterilization were included in this study.
Before treatment, the existence of Helicobacter pylori can be confirmed by one or more of the following methods: rapid urease test, Hp culture, 13C urea breath test, 14C urea breath test and stool Hp antigen test.

Sponsors & Collaborators

Zhang Xiaofeng,MD
Otherlead

Study Sites (1)

Hangzhou first people's Hospital

Hangzhou, Zhejiang, 310000, China

MeSH Terms

Interventions

tegoprazanTabletsEsomeprazoleBID protein, humanAmoxicillin

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical PreparationsOmeprazole2-PyridinylmethylsulfinylbenzimidazolesSulfoxidesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Enrollment

370 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: chief physician

Study Record Dates

First Submitted

November 23, 2022

First Posted

December 12, 2022

Study Start

November 1, 2023

Actual (reported)

Tegoprazan-Amoxicillin Dual Therapy vs. Bismuth Quadruple Therapy for H. Pylori Infection (TATH-1)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Tegoprazan 50mg QD

Esomeprazole 20 mg BID

Tegoprazan 50 mg BID

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (3)

Tegoprazan 50mg QD

Esomeprazole 20 mg BID

Tegoprazan 50 mg BID

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations