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

Helicobacter Pylori Infection Clinical Trial

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）

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05870683
• Other study ID #: SHARE2301
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: July 2023
• Source: Shandong University
• Contact: Yanqing Li, MD
• Phone: 18560086667
• Email: qlxhkqz[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 368
• Est. completion date: December 30, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• Tegoprazan
Included in dual eradication medication.
• Amoxicillin
Included in dual eradication medication.
• Esomeprazole
Included in dual eradication medication.

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (8)

Lead Sponsor	Collaborator
Yanqing Li	Linyi People's Hospital, The Affiliated Hospital of Qingdao University, The People's Hospital of Jimo, The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine, Weifang Medical University, Yuncheng Traditional Chinese Medicine Hospital, Zhengzhou Central Hospital

Country where clinical trial is conducted

China, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate	Both 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.	Immediately after follow-up check
Secondary	Rate of adverse reactions	Rate of adverse reactions	Immediately after follow-up check
Secondary	Patient compliance	good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken	Immediately after follow-up check