Clinical trial NCT05870683: Comparison of Two Dual Therapies in the First-line Treatment of Helicobacter Pylori Infection （SHARE2301）
Official title: Comparison of the Efficacy of Tegoprazan-containing Versus Esomeprazole-containing Dual Therapy for Helicobacter Pylori Eradication: a Prospective, Multicenter, Randomized Controlled Study （SHARE2301）
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Helicobacter Pylori Infection
Lead sponsor: Shandong University
Sponsor class: OTHER
Collaborators: name: Linyi People's Hospital
name: Weifang Medical University
name: Zhengzhou Central Hospital
name: Yuncheng Traditional Chinese Medicine Hospital
name: The Affiliated Hospital of Qingdao University
name: The People's Hospital of Jimo
name: Shandong University of Traditional Chinese Medicine
First posted: 2023-05-23
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Eradication rate
timeFrame: Immediately after follow-up check
Secondary outcomes:
measure: Rate of adverse reactions
timeFrame: Immediately after follow-up check
measure: Patient compliance
timeFrame: Immediately after follow-up check
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yanqing Li
role: STUDY_CHAIR
References:
citation: Malfertheiner P, Megraud F, O'Morain CA, Gisbert JP, Kuipers EJ, Axon AT, Bazzoli F, Gasbarrini A, Atherton J, Graham DY, Hunt R, Moayyedi P, Rokkas T, Rugge M, Selgrad M, Suerbaum S, Sugano K, El-Omar EM; European Helicobacter and Microbiota Study Group and Consensus panel. Management of Helicobacter pylori infection-the Maastricht V/Florence Consensus Report. Gut. 2017 Jan;66(1):6-30. doi: 10.1136/gutjnl-2016-312288. Epub 2016 Oct 5.