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

NCT05870683 | Unknown

• 1 other identifier: SHARE2301
• Study Type: interventional
• Target: 368
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rate of adverse reactions

  Immediately after follow-up check

• Patient compliance

  Immediately after follow-up check

Study Arms (2)

14-day Tegoprazan-Amoxicillin dual therapy

EXPERIMENTAL

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; Drug: Amoxicillin

14-day Esomeprazole-Amoxicillin dual therapy

ACTIVE COMPARATOR

14-day Esomeprazole-Amoxicillin dual therapy, Esomeprazole（Astrazeneca Pharmaceutical Co., LTD.) 20mg qid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid

Drug: Amoxicillin; Drug: Esomeprazole

Interventions

Tegoprazan DRUG

Included in dual eradication medication.

14-day Tegoprazan-Amoxicillin dual therapy

Amoxicillin DRUG

Included in dual eradication medication.

14-day Esomeprazole-Amoxicillin dual therapy; 14-day Tegoprazan-Amoxicillin dual therapy

Esomeprazole DRUG

Included in dual eradication medication.

14-day Esomeprazole-Amoxicillin dual therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yanqing Li: lead
• Linyi People's Hospital: collaborator
• Weifang Medical University: collaborator
• Zhengzhou Central Hospital: collaborator
• Yuncheng Traditional Chinese Medicine Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• The People's Hospital of Jimo: collaborator
• Shandong University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 27707777 RESULT

• Kong Q, Mirza IA, Zhang X, Song X, Li X, Zhang Q, Xu L, Guo Y, Yu Y, Zuo X, Li Y, Li Y. Fourteen-Day Tegoprazan-Amoxicillin Dual Therapy as the First-Line Treatment of Helicobacter pylori Infection (SHARE2301): A Multicenter, Noninferiority, Randomized Clinical Trial. Helicobacter. 2024 May-Jun;29(3):e13098. doi: 10.1111/hel.13098.

  PMID: 38853394 DERIVED

MeSH Terms

Interventions

tegoprazan; Amoxicillin; Esomeprazole

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Officials

• Yanqing Li

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Yanqing Li, MD

CONTACT

18560086667; qlxhkqz@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice-President

Study Record Dates

• First Submitted: May 7, 2023
• First Posted: May 23, 2023
• Study Start: May 24, 2023
• Primary Completion: October 1, 2023
• Study Completion: December 30, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)