14-day Double Therapy Versus Bismuth Quadruple Therapy in First-line Treatment of Helicobacter Pylori Infection

NCT05438550 | Unknown Phase 4

• 1 other identifier: 2022SDU-QILU-G003
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomized to 14 days of dual therapy with Tegoprazan or 14 days of quadruple therapy with bismuth for eradication. At 6 weeks after treatment, subjects underwent another 13C-urea breath test. The eradication rate, adverse reaction rate and patient compliance were calculated.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori Infection; High dose dual therapy; Bismuth-containing quadruple therapy

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 90% of the study medications and complete follow-up.

  immediately after the procedure

Secondary Outcomes (2)

• Rate of adverse reactions

  Immediately after the procedure

• Patient compliance

  Immediately after the procedure

Study Arms (2)

14-day bismuth-containing quadruple therapy (BQT)

ACTIVE COMPARATOR

14-day bismuth-containing quadruple therapy (BQT) Nexium (Esomeprazole, Astrazeneca Pharmaceutical Co., LTD.) 20mg bid Amoxicillin (Amoxicillin, United Laboratories Co., LTD) 1000mg bid Tetracycline (Huanan Brand, Guangdong Huanan Pharmaceutical Co. LTD.) 500mg qid Bismuth potassium Citrate (Lizhu Delle, Lizhu Group Pharmaceutical Factory) 2g bid

Drug: 14-day high-dose Tegoprazan Dual Therapy (HDDT)

14-day Tegoprazan high-dose dual therapy (HDDT)

EXPERIMENTAL

14-day Tegoprazan high-dose dual therapy (HDDT) Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid

Drug: 14-day high-dose Tegoprazan Dual Therapy (HDDT)

Interventions

14-day high-dose Tegoprazan Dual Therapy (HDDT) DRUG

14-day Tegoprazan high-dose dual therapy (HDDT) Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid To investigate the efficacy of high-dose dual therapy of Tegoprazan, a novel p-CAB acid suppressant, combined with amoxicillin for the eradication of Helicobacter pylori

Also known as: Tegoprazan (Rosin Pharmaceutical Group Co. LTD.) 50mg bid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid

14-day Tegoprazan high-dose dual therapy (HDDT); 14-day bismuth-containing quadruple therapy (BQT)

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 Helicobacter pylori culture, histopathological test, rapid urease test, C13/C14 urea breath test, or helicobacter pylori antigen test in feces).
• 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.
• 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

• Shandong University: lead

Study Sites (1)

Qilu hosipital

Jinan, Shandong, 250012, China

Location

MeSH Terms

Interventions

tegoprazan; BID protein, human; Amoxicillin

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

Study Officials

• Xiuli Zuo

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiuli Zuo, MD, PhD

CONTACT

86 15588818685; zuoxiuli@sdu.edu.cn

Xiuli Zuo, MD,PhD

CONTACT

86 15588818685; zuoxiuli@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctoral supervisor of Qilu Hospital gastroenterology department

Model Details: A prospective, randomized, controlled study

Study Record Dates

• First Submitted: June 20, 2022
• First Posted: June 30, 2022
• Study Start: February 14, 2023
• Primary Completion: December 20, 2023
• Study Completion: December 31, 2023
• Last Updated: February 14, 2023

Record last verified: 2023-02

Locations

CN (1)