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

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

Overview

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.

Interventions

• Drug Anaprazole Sodium enteric-coated tablet
  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
• Drug Esomeprazole magnesium enteric-coated tablets
  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

Primary outcome measures

• 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)]

Secondary outcome measures (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 [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)]

Eligibility criteria

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).
• 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.
• 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 .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 1 center

• Shenzhen Hospital of Southern Medical University — Shenzhen

Identifiers

NCT: NCT07606833 · 3571-HP-3001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗