A Phase 4 interventional study of 14-day high-dose Tegoprazan Dual Therapy (HDDT) in Helicobacter Pylori Infection, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-02-14.
Sponsored by Shandong University · Phase 4, Interventional, and Treatment
The researchers collected untreated H. pylori positive patients from outpatient clinics. Subjects were randomized to 14 days of dual therapy with Tegoprazan or 14 days of quadruple therapy with bismuth for eradication. At 6 weeks after treatment, subjects underwent another 13C-urea breath test. The eradication rate, adverse reaction rate and patient compliance were calculated.
Confirm the inclusion of patients: fill in the case report form and enter group A or group B according to the randomization results.
Group A: 14-day Tegoprazan high-dose dual therapy (HDDT) Tegoprazan 50mg bid Amoxicillin 750mg qid Group B: 14-day bismuth-containing quadruple therapy (BQT) Esomeprazole 20mg bid Amoxicillin 1000mg bid Tetracycline 500mg qid Potassium bismuth citrate 2g bid
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 258 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.
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Exclusion Criteria:
14-day bismuth-containing quadruple therapy (BQT) Nexium (Esomeprazole, Astrazeneca Pharmaceutical Co., LTD.) 20mg bid Amoxicillin (Amoxicillin, United Laboratories Co., LTD) 1000mg bid Tetracycline (Huanan Brand, Guangdong Huanan Pharmaceutical Co. LTD.) 500mg qid Bismuth potassium Citrate (Lizhu Delle, Lizhu Group Pharmaceutical Factory) 2g bid
Drug: 14-day high-dose Tegoprazan Dual Therapy (HDDT)
14-day Tegoprazan high-dose dual therapy (HDDT) Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid
Drug: 14-day high-dose Tegoprazan Dual Therapy (HDDT)
14-day Tegoprazan high-dose dual therapy (HDDT) Tegoprazan（Luo Xin Pharmaceutical Group Co. LTD）50mg bid Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid To investigate the efficacy of high-dose dual therapy of Tegoprazan, a novel p-CAB acid suppressant, combined with amoxicillin for the eradication of Helicobacter pylori
Also known as: Tegoprazan (Rosin Pharmaceutical Group Co. LTD.) 50mg bid, Amoxicillin (Amoxicillin, United Laboratories Co. LTD) 750mg qid
Eradication rate
Both intention to treat (ITT) and per-protocol (PP) analyses will be used for the assessment of the eradication rates of Helicobacter pylori infections in two groups. The ITT analysis includes all randomly assigned patients who take at least one dose of the study medications. The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.
Time frame: immediately after the procedure
Rate of adverse reactions
Rate of adverse reactions
Time frame: Immediately after the procedure
Patient compliance
Good compliance is defined as the actual dosage is within the range of 80%-100% of the dosage that should be taken.
Time frame: Immediately after the procedure
This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Shandong University