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Comparison of Two Dual Therapies in the First-line Treatment of Helicobacter Pylori Infection (SHARE2301)

Comparison of the Efficacy of Tegoprazan-containing Versus Esomeprazole-containing Dual Therapy for Helicobacter Pylori Eradication: a Prospective, Multicenter, Randomized Controlled Study (SHARE2301)

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05870683
Enrollment
368
Registered
2023-05-23
Start date
2023-05-24
Completion date
2023-12-30
Last updated
2023-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

Brief summary

Helicobacter pylori (H. pylori) infection is a common global infectious disease of the gastrointestinal tract. Helicobacter pylori eradication can effectively prevent the development of stomach cancer. Progressive application of dual therapy for the eradication of Helicobacter pylori. Tegoprazan, a Potassium-Competitive Acid Blockers. The efficacy of P-CAB agents represented by vonoprazan in H. pylori eradication therapy has been widely verified.

Detailed description

In 1989, it was suggested that amoxicillin combined with PPI could eradicate Hp infection, and in 2015, a prospective, multicenter, randomized controlled study in Taiwan with a large sample showed that the eradication rate of Hp could reach 96.6% with dual therapy for primary treatment of Hp infection, and the results of intention-to-treat analysis were as high as 95.3%. 95.3%. In 2020, a meta-analysis showed that high-dose dual therapy had the same efficacy and fewer side effects than other recommended regimens in first-line treatment. In terms of dosing days, multiple randomized controlled studies and meta-analyses from 2020-2021 have shown that 14 days of high-dose dual therapy is more effective in eradicating H. pylori. Tegoprazan, a Potassium-Competitive Acid Blockers (P-CAB), is a new type of acid-suppressing drug that compensates for the short half-life of acid-activated traditional acid-suppressing PPI and the low mucosal healing rate due to insufficient acid suppression. The efficacy of P-CAB agents represented by vonoprazan in H. pylori eradication therapy has been widely verified. 2022, tegoprazan was approved by the State Drug Administration for the new indication of eradication of H. pylori infection in adults in combination with appropriate antimicrobial therapy, and its efficacy in clinical application has not yet been verified.

Interventions

Included in dual eradication medication.

DRUGAmoxicillin

Included in dual eradication medication.

DRUGEsomeprazole

Included in dual eradication medication.

Sponsors

Linyi People's Hospital
CollaboratorOTHER
Weifang Medical University
CollaboratorOTHER
Zhengzhou Central Hospital
CollaboratorOTHER
Yuncheng Traditional Chinese Medicine Hospital
CollaboratorOTHER
The Affiliated Hospital of Qingdao University
CollaboratorOTHER
The People's Hospital of Jimo
CollaboratorUNKNOWN
Shandong University of Traditional Chinese Medicine
CollaboratorOTHER
Yanqing Li
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Helicobacter pylori infection (either positive for histopathological test, rapid urease test, or C13/C14 urea breath test). * Patients who have not previously received helicobacter pylori eradication therapy.

Exclusion criteria

* Serious underlying diseases, such as liver insufficiency, renal insufficiency, immunosuppression, malignant tumor, coronary heart disease (angina pectoris or coronary artery stenosis ≥ 75%). * Those who are not willing to take contraceptive measures during pregnancy, lactation or the trial. * Active gastrointestinal bleeding. * History of drug allergy. * History of upper gastrointestinal surgery. * Medication history of bismuth, antibiotics and PPI within 4 weeks. * Other behaviors that may increase the risk, such as alcohol and drug abuse. * Unable or unwilling to provide informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Eradication rateImmediately after follow-up checkBoth intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 80% of the study medications and complete follow-up.

Secondary

MeasureTime frameDescription
Patient complianceImmediately after follow-up checkgood compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken
Rate of adverse reactionsImmediately after follow-up checkRate of adverse reactions

Countries

China

Contacts

Primary ContactYanqing Li, MD
qlxhkqz@163.com18560086667

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026