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

NCT07606833 | Not Yet Recruiting Phase 3

• 1 other identifier: 3571-HP-3001
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HELICOBACTER PYLORI INFECTIONS

Outcome Measures

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

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

Secondary Outcomes (2)

• 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

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

• 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

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

Other Outcomes (8)

• Number of Subjects With Adverse Events (AEs)

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

• AUC0-t

  Up to 14 days from the start of administration

• AUC0-∞

  Up to 14 days from the start of administration

Study Arms (2)

Anaprazole sodium enteric-coated tablets

EXPERIMENTAL

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

Esomeprazole magnesium enteric-coated tablets

ACTIVE COMPARATOR

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

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

Anaprazole sodium enteric-coated tablets

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

Esomeprazole magnesium enteric-coated tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• Participants in the trial had previously undergone surgeries or procedures that might affect gastric acid secretion or drug absorption.
• 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).
• 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.
• 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).
• Previously received Helicobacter pylori eradication treatment.
• 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.
• Those with chronic drug abuse in the 12 months prior to screening.
• Those with alcohol dependence in the 12 months prior to screening.
• Participated used experimental drugs/devices in other drug/device clinical studies within 3 months before screening.
• 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.
• Others were deemed unsuitable for the trial .

Sponsors & Collaborators

• Xuanzhu Biopharmaceutical Co., Ltd.: lead

Study Sites (1)

Shenzhen Hospital of Southern Medical University

Shenzhen, Guangdong, 518100, China

Location

Central Study Contacts

Yaping Luo

CONTACT

+86-15367827140; luoyaping@xuanzhubio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 26, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): February 19, 2027
• Study Completion (Estimated): March 18, 2027
• Last Updated: May 26, 2026

Record last verified: 2026-05

Locations

CN (1)