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The Clinical Trail to Evaluate the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Combined With Bismuth-containing Quadruple Therapy in Eradicating Helicobacter Pylori

ConditionHELICOBACTER PYLORI INFECTIONS
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXuanzhu Biopharmaceutical Co., Ltd.

About this trial

This is a multicenter, randomized, double blind, double-simulated, parallel control of positive drug phase III clinical study to evaluate the efficacy and safety of Anaprazole versus Esomeprazole-containing Bismuth quadruple therapy for eradication of Helicobacter pylori in China.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Aged 18-75 years

During the screening visit, the participants were determined to be Hp-positive by 13C-UBT and Hp eradication therapy was required by the investigator.

Fully understand the content of the experiment, voluntarily participate in the experiment, and sign the informed consent.

Disqualifiers

Known allergic history to Anaprazole or Esomeprazole, or amoxicillin or clarithromycin and bismuth(including any related excipients ).

Have a history of severe rapid-onset hypersensitivity to β-lactam agents (such as cephalosporins, carbapenems, monocyclic β-lactam).

The participant has Zollinger-Ellison syndrome.

Participants known to have acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric mucosal injury (AGML) or acute duodenal mucosal injury (ADML).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Anaprazole Sodium enteric-coated tablet

    Drug

    Anaprazole sodium enteric-coated tablets 20mg + Esomeprazole magnesium enteric-coated tablets placebo 1 tablet +Bismuth potassium citrate capsules 240mg + Amoxicillin capsules 1000mg + Clarithromycin tablets 500mg,BID,oral,twice daily for 14 days

  • Esomeprazole magnesium enteric-coated tablets

    Drug

    Anaprazole sodium enteric-coated tablets placebo 1 tablet + Esomeprazole magnesium enteric-coated tablets20mg +Bismuth potassium citrate capsules 240mg + Amoxicillin capsules 1000mg + Clarithromycin tablets 500mg,BID,oral,twice daily for 14 days

Treatment groups

556 Participants
are divided into 2 treatment groups
Group A: Anaprazole sodium enteric-coated tabletsExperimental treatment 1 intervention
Group B: Esomeprazole magnesium enteric-coated tabletsActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of all participants with successful Helicobacter Pylori (Hp) eradication

Percentage of all patients with Hp eradication determined by a 13\^C-urea breath test after study treatment

Time frame
Day 28+7 days following the completion of treatment(duration of treatment was 2 weeks)

Secondary outcomes

1

Percentage of participants with successful Helicobacter Pylori (H.Pylori) eradication in participants with Clarithromycin-resistant strain and Clarithromycin-sensitive strain of H.Pylori at baseline

Time frame
Day 28+7 days following the completion of treatment(duration of treatment was 2 weeks)
2

Percentage of participants with successful Helicobacter Pylori (H.Pylori) eradication in participants with Amoxicillin-resistant strain and Amoxicillin-sensitive strain of H.Pylori at baseline

Time frame
Day 28+7 days following the completion of treatment(duration of treatment was 2 weeks)

Other outcomes

1

Number of Subjects With Adverse Events (AEs)

Time frame
Day 15+3 days following the completion of treatment(duration of treatment was 2 weeks)
2

AUC0-t

Time frame
Up to 14 days from the start of administration
3

AUC0-∞

Time frame
Up to 14 days from the start of administration
4

Cmax

Time frame
Up to 14 days from the start of administration

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuanzhu Biopharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: