A Phase 4 interventional study of Vonoprazan and Tetracycline 500mg tid in Gastritis, Indigestion, Helicobacter Pylori Infection, Gastric Cancer, Peptic Ulcer, sponsored by Yongquan Shi. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Yongquan Shi · Phase 4, Interventional, and Treatment
This study aims to evaluate the efficacy of vonoprazan combined with different antibiotics in dual therapy for Helicobacter pylori eradication treatment. Newly infected patients were randomly assigned to four groups: amoxicillin dual therapy, tetracycline dual therapy, minocycline dual therapy, and bismuth quadruple therapy. At the follow - up visit in the 6th week, urea breath test, rapid urease test, or Helicobacter pylori fecal antigen test will be conducted to confirm eradication.
The study will include three phases: screening, treatment and follow-up. Screening: this phase will last a maximum of 14 days and subjects eligibility will be evaluated after signing informed consent. One of urea breath test#rapid urease test or helicobacter pylori stool antigen test will be performed in addition to the baseline routine evaluations.
Treatment: Subjects are randomly assigned to treatment and will be treated for 14 days. A randomization visit will take place on Day 0 and an end-of-treatment visit will take place between day 14 and 16.
Follow-up: includes one visits. Approximately 28 days after the end of treatment. Eradication of H. Pylori will be confirmed by one of urea breath test#rapid urease test or helicobacter pylori stool antigen test.
135 studies on the registry are indexed under Gastritis; 23 are open to participants now.
This study's planned enrollment of 400 is above the median of 200 across 97 interventional studies indexed under Gastritis.
Browse Gastritis studies →Yongquan Shi is the lead sponsor of 9 studies on the registry; 8 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days
Drug: Vonoprazan · Drug: Amoxicillin
Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days
Drug: Vonoprazan · Drug: Tetracycline 500mg tid
Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days
Drug: Vonoprazan · Drug: Minocycline
Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
Drug: Vonoprazan · Drug: Bismuth · Drug: Clarithromycin 500 mg · Drug: Amoxicillin
Vonoprazan - amoxicillin dual therapy: Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days; Vonoprazan-tetracycline dual therapy:Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days; Vonoprazan-minocycline dual therapy:Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days; Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
Also known as: Vonoprazan - amoxicillin dual therapy
Vonoprazan-tetracycline dual therapy:Vonorazon 20 mg daily for 14 days # tetracycline 500 mg by mouth three time daily for 14 days
Vonoprazan-minocycline dual therapy Vonorazon 20 mg daily for 14 days # minocycline 100 mg by mouth two time daily for 14 days
Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
Vonoprazan - amoxicillin dual therapy:Vonorazon 20 mg daily for 14 days # amoxicillin 1000 mg by mouth three time daily for 14 days; Bismuth-containing quadruple therapy:Amoxicillin 1000 mg, clarithromycin 500 mg, vonoprazan 20 mg, and colloidal bismuth tartrate 220 mg, all twice a day for 14 days
Helicobacter pylori eradication
The primary end point of this study is H.pylori eradication#established by negative \[13C\] urea breath test #DOB value below 3.9#28 days after the end of eradication
Time frame: 28 days after treatment
adverse events
Participants with Adverse Events as a Measure of Safety and Tolerability.The common side effects of the study include headache,dizziness,skin rash,other gastrointestinal disorders,pyrexia,cough and back pain
Time frame: 14 days of treatment, and 28 days after treatment
Plan to share: No
Started Apr 2025 (actual). Primary completion is estimated for Oct 2025, 6 months after the start.
Of 14 phase 4 interventional studies under Gastritis, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 14. This study's planned 6 months is below that.
How these figures are worked out, and which studies are left out of them.
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Yongquan Shi