The Clinical Trail to Evaluate the Efficacy and Safety of Anaprazole Sodium Enteric-coated Tablet… (NCT07606833) | Clinical Trial Compass
Not Yet RecruitingPhase 3
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
China556 participantsStarted 2026-06-10
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of all participants with successful Helicobacter Pylori (Hp) eradication
Timeframe: Day 28+7 days following the completion of treatment(duration of treatment was 2 weeks)
. 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.
. 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).