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）

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.

Study Overview

• Status: Recruiting
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Tegoprazan; Drug: Amoxicillin; Drug: Esomeprazole

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.

• Study Type: Interventional
• Enrollment (Estimated): 368
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yanqing Li, MD; Phone Number: 18560086667; Email: qlxhkqz@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Department of Gastroenterology, Qilu Hospital, Shandong University
      • Contact: Yanqing Li, PhD. MD.; Phone Number: 18678827666; Email: liyanqing@sdu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 14-day Tegoprazan-Amoxicillin dual therapy; 14-day Tegoprazan-Amoxicillin dual therapy, Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid	Drug: Tegoprazan; Included in dual eradication medication.; Drug: Amoxicillin; Included in dual eradication medication.
Active Comparator: 14-day Esomeprazole-Amoxicillin dual therapy; 14-day Esomeprazole-Amoxicillin dual therapy, Esomeprazole（Astrazeneca Pharmaceutical Co., LTD.) 20mg qid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid	Drug: Amoxicillin; Included in dual eradication medication.; Drug: Esomeprazole; Included in dual eradication medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of adverse reactions	Rate of adverse reactions	Immediately after follow-up check
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

Collaborators and Investigators

• Sponsor: Yanqing Li
• Collaborators: The Affiliated Hospital of Qingdao University; The Second Affiliated Hospital of Shandong University of traditional Chinese Medicine; Linyi People's Hospital; Weifang Medical University; Yuncheng Traditional Chinese Medicine Hospital; Zhengzhou Central Hospital; The People's Hospital of Jimo
• Investigators: Study Chair: Yanqing Li, Qilu Hospital of Shandong University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 24, 2023
• Primary Completion (Estimated): October 1, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: May 7, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): July 11, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Amoxicillin; Esomeprazole
• Other Study ID Numbers: SHARE2301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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