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Efficacy of Different Durations of Dual and Quadruple Regimens for Helicobacter Pylori Eradication

ConditionHELICOBACTER PYLORI INFECTIONS
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShandong University

About this trial

The study aimed to compare the efficacy and safety of dual and quadruple regimens with different durations (7-day, 10-day, 14-day) for the eradication of Helicobacter pylori. Subjects were randomized to receive the intervention and were reviewed by 13C-urea breath test after 6 weeks. The eradication rates, adverse reaction rates and patient adherence were calculated.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-70 years old

Patients with H.pylori infection (13C/14C-urea breath test)

Patients without previous treatment for H. pylori eradication

Disqualifiers

Patients with serious underlying diseases, such as liver insufficiency (Aspartate aminotransferase or alanine aminotransferase greater than the normal value), renal insufficiency (Cr≥2.0mg/dL or glomerular filtration rate <50 ml/min), immunosuppression, malignant tumors, Coronary heart disease or coronary artery stenosis ≥75%

Patients with active gastrointestinal bleeding

Patients with a history of upper gastrointestinal surgery

Patients allergic to treatment drugs

Trial design

Design model

Parallel

Treatments tested in this trial

  • vonoprazan+amoxicillin

    Drug

    Drug combinations for dual regimens：vonoprazan+amoxicillin

  • Duration of eradication regimen: 7-day

    Other intervention

    Duration of eradication regimen: 7-day

  • vonoprazan+amoxicillin+tetracycline+bismuth

    Drug

    Drug combinations for quadruple regimens: vonoprazan+amoxicillin+tetracycline+bismuth

  • Duration of eradication regimen: 10-day

    Other intervention

    Duration of eradication regimen: 10-day

  • Duration of eradication regimen: 14-day

    Other intervention

    Duration of eradication regimen: 14-day

Treatment groups

330 Participants
are divided into 3 treatment groups
Group A: 14-day dual regimenActive comparator 2 interventions
Group B: 10-day dual regimenExperimental treatment 2 interventions
Group C: 7-day quadruple regimenExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Eradication rate

13C-urea breath test was used to determine whether eradication was successful. 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 the three 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.

Time frame
Six weeks after treatment

Secondary outcomes

1

Rate of adverse reactions

Drug-related adverse reactions needs to be recorded after treatment

Time frame
Immediately after treatment
2

Patient compliance

The number of missed and overdosed doses of medication needs to be completed after treatment.

Time frame
Immediately after treatment

Other outcomes

Sponsors and contacts

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Shandong University

Lead sponsor

Zibo Maternal and Child Health Hospital

Collaborator

Zaozhuang Municipal Hospital

Collaborator

Feicheng Municipal People's Hospital

Collaborator

Shandong University of Traditional Chinese Medicine

Collaborator

The People's Hospital of Jimo.Qingdao

Collaborator

Dezhou Hospital Qilu Hospital of Shandong University

Collaborator

Source ClinicalTrials.gov
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