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Not yet recruitingNCT07606833Updated May 26, 2026

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

A Phase 3 interventional study of Anaprazole Sodium enteric-coated tablet and Esomeprazole magnesium enteric-coated tablets in HELICOBACTER PYLORI INFECTIONS, sponsored by Xuanzhu Biopharmaceutical Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-05-26.

Sponsored by Xuanzhu Biopharmaceutical Co., Ltd. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
556
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • HELICOBACTER PYLORI INFECTIONS
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Aged 18-75 years
  2. During the screening visit, the participants were determined to be Hp-positive by 13C-UBT and Hp eradication therapy was required by the investigator.
  3. Fully understand the content of the experiment, voluntarily participate in the experiment, and sign the informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Known allergic history to Anaprazole or Esomeprazole, or amoxicillin or clarithromycin and bismuth(including any related excipients ).
  2. Have a history of severe rapid-onset hypersensitivity to β-lactam agents (such as cephalosporins, carbapenems, monocyclic β-lactam).
  3. The participant has Zollinger-Ellison syndrome.
  4. Participants known to have acute upper gastrointestinal bleeding, active gastric or duodenal ulcer, acute gastric mucosal injury (AGML) or acute duodenal mucosal injury (ADML).
  5. Participants in the trial had previously undergone surgeries or procedures that might affect gastric acid secretion or drug absorption.
  6. Participants with a history of malignant tumors within 5 years prior to screening (Cutaneous basal cell carcinoma or cervical carcinoma in situ that has been cured is excluded).
  7. The subject has severe central nervous system, cardiovascular, respiratory, liver, kidney, gastrointestinal, urinary, endocrine or hematological diseases that the investigator believes may affect the study results and the safety of the participants.
  8. Laboratory examination during the screening period showed ALT or AST > 2 times of the upper limit of normal value, TBIL > 1.5 times of the upper limit of normal value; renal function Cr > 1.5 times of the upper limit of normal value (one review was allowed in the study, and those who still did not meet the requirements for inclusion were excluded).
  9. Participants with severe arrhythmia, multigenic premature ventricular contractions (PVC), second-degree or higher atrioventricular block, ventricular arrhythmia or prolonged QT interval (QTcF> 450ms in male and 470ms in female).
  10. Previously received Helicobacter pylori eradication treatment.
  11. Used PPI or P-CAB preparations within 2 weeks before 13C-UBT examination during the screening period; Antibiotics, bismuth-containing preparations, or traditional Chinese medicine with antibacterial effects were used within 4 weeks before 13C-UBT test during the screening period.
  12. Those with chronic drug abuse in the 12 months prior to screening.
  13. Those with alcohol dependence in the 12 months prior to screening.
  14. Participated used experimental drugs/devices in other drug/device clinical studies within 3 months before screening.
  15. Female participants who are suspected or already pregnant, breastfeeding; and female participant or a partner of male participant who are planning to become pregnant during the study.
  16. Others were deemed unsuitable for the trial .
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
556 participants (estimated)

Study arms

  • Experimental
    Anaprazole sodium enteric-coated tablets

    Anaprazole sodium enteric-coated tablets + Esomeprazole magnesium enteric-coated tablets placebo +Bismuth potassium citrate capsules + Amoxicillin capsules + Clarithromycin tablets

    Drug: Anaprazole Sodium enteric-coated tablet

  • Active comparator
    Esomeprazole magnesium enteric-coated tablets

    Anaprazole sodium enteric-coated tablets placebo + Esomeprazole magnesium enteric-coated tablets +Bismuth potassium citrate capsules + Amoxicillin capsules + Clarithromycin tablets

    Drug: Esomeprazole magnesium enteric-coated tablets

Interventions

  • DrugAnaprazole Sodium enteric-coated tablet

    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

  • DrugEsomeprazole magnesium enteric-coated tablets

    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

05

What researchers measure

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

  5. Tmax

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

  6. t½

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

  7. CL/F

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

  8. Vz/F

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

06

Study locations

1 site
  • Shenzhen Hospital of Southern Medical University
    Shenzhen, Guangdong 518100, China
07

Registry details

Key details

Study ID
NCT07606833
Lead sponsor
Xuanzhu Biopharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
May 26, 2026
Start date
Jun 10, 2026 (estimated)
Primary completion
Feb 19, 2027 (estimated)
Completion
Mar 18, 2027 (estimated)
Last update
May 26, 2026

Study contacts

Yaping Luo
Contact
luoyaping@xuanzhubio.com
+86-15367827140

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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