HELICOBACTER PYLORI INFECTIONSPhase 3NCT07606833
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 study testing Anaprazole Sodium enteric-coated tablet and Esomeprazole magnesium enteric-coated tablets in people with HELICOBACTER PYLORI INFECTIONS, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HELICOBACTER PYLORI INFECTIONS
- What is being tested?
- Anaprazole Sodium enteric-coated tablet and Esomeprazole magnesium enteric-coated tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 556 participants
- Where
- 1 siteChina
- Study dates
- 10 Jun 2026to 18 Mar 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
- 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).
- 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 .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, 518100
Ye Chen, +86-13922293223, yechen_fimmu@163.com
Ye Chen, PhD
About this study
Official title: A Multicenter, Randomized, Double Blind, Double-simulated, Parallel Control of Positive Drug Phase III Clinical Study Evaluating the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Containing Bismuth in Quadruple Therapy for the Eradication of Helicobacter Pylori
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
- Being tested
- Anaprazole Sodium enteric-coated tablet, Esomeprazole magnesium enteric-coated tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anaprazole Sodium enteric-coated tabletDrug
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 tabletsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Esomeprazole magnesium enteric-coated tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Day 28+7 days following the completion of treatment(duration of treatment was 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start10 Jun 2026 (estimated)
- Primary completion19 Feb 2027 (estimated)
- Study completion18 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HELICOBACTER PYLORI INFECTIONSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 556 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07606833
- Sponsor's protocol ID
- 3571-HP-3001
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double Blind, Double-simulated, Parallel Control of Positive Drug Phase III Clinical Study Evaluating the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablets Containing Bismuth in Quadruple Therapy for the Eradication of Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT07606833
- Acronym / sponsor ID
- 3571-HP-3001
- Conditions
- HELICOBACTER PYLORI INFECTIONS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 556 participants (estimated)
- Lead sponsor
- Xuanzhu Biopharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Jun 2026 (estimated)
- Primary completion
- 19 Feb 2027 (estimated)
- Study completion
- 18 Mar 2027 (estimated)
- First posted
- 26 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anaprazole sodium enteric-coated tablets | Experimental | Drug: Anaprazole Sodium enteric-coated tabletAnaprazole sodium enteric-coated tablets + Esomeprazole magnesium enteric-coated tablets placebo +Bismuth potassium citrate capsules + Amoxicillin capsules + Clarithromycin tablets |
| Esomeprazole magnesium enteric-coated tablets | Active comparator | Drug: Esomeprazole magnesium enteric-coated tabletsAnaprazole sodium enteric-coated tablets placebo + Esomeprazole magnesium enteric-coated tablets +Bismuth potassium citrate capsules + Amoxicillin capsules + Clarithromycin tablets |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anaprazole Sodium enteric-coated tabletAnaprazole 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 | Drug | Anaprazole sodium enteric-coated tablets |
| Esomeprazole magnesium enteric-coated tabletsAnaprazole 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 | Drug | Esomeprazole magnesium enteric-coated tablets |
Primary outcome
Percentage of all participants with successful Helicobacter Pylori (Hp) eradication
Time frame: Day 28+7 days following the completion of treatment(duration of treatment was 2 weeks)
Percentage of all patients with Hp eradication determined by a 13^C-urea breath test after study treatment
2 secondary outcomes
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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Anaprazole Sodium enteric-coated tablet and Esomeprazole magnesium enteric-coated tablets in people with HELICOBACTER PYLORI INFECTIONS, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yaping Luo (+86-15367827140, luoyaping@xuanzhubio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of all participants with successful Helicobacter Pylori (Hp) eradication (time frame: Day 28+7 days following the completion of treatment(duration of treatment was 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.