Helicobacter Rescue Therapy With High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

Phase 4

Completed

• Conditions: Gastritis; Dyspepsia; Helicobacter Pylori Infection; Gastric Cancer; Peptic Ulcer
• Interventions: Drug: Esomeprazole; Drug: Bismuth; Drug: Amoxicillin; Drug: Tetracycline; Drug: Furazolidone

• Registration Number: NCT04678492
• Lead Sponsor: Xijing Hospital of Digestive Diseases

Brief Summary

This study aims at evaluating efficacy and safety of high-dose esomeprazole and amoxicillin dual therapy(esomeprazole and amoxicillin) versus bismuth-containing quadruple Therapy(bismuth，esomeprazole，tetracycline and furazolidone) in H. pylori rescue therapy. It is hypothesized that high-dose esomeprazole and amoxicillin dual therapy is non-inferior to bismuth-containing quadruple Therapy. Patients with confirmed failure of H. pylori eradication will be randomized to one of the treatments described above. At week 6 follow-up visits, a urea breath test，rapid urease test or helicobacter pylori stool antigen test will be performed to confirm eradication.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-12-13
• Study First Submitted QC: 2020-12-16
• Study Start: 2020-12-20
• Study First Posted: 2020-12-22
• Primary Completion: 2021-12-20
• Study Completion: 2021-12-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-29
• Last Update Posted: 2023-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 658

Inclusion Criteria

1. Patients who had failed H.pylori eradication therapies before.
2. Age between 18~70, both gender.
3. Patients who had failed H.pylori eradication therapies during last 2 years and stop the eradication therapies for at least 3 months.
4. Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion Criteria

1. Patients are excluded if they have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.
2. Contraindications to study drugs.
3. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
4. Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the [13C] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).
5. Pregnant or lactating women.
6. Underwent upper gastrointestinal Surgery.
7. Patients with moderate or severe atypical hyperplasia or high-grade intraepithelial neoplasia.
8. have symptom of dysphagia.
9. Evidence of bleeding or iron efficiency anemia.
10. A history of malignancy.
11. Drug or alcohol abuse history in the past 1 year.
12. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
13. a person with a mental disorder.
14. Enrolled in other clinical trials in the past 3 months.
15. Refuse to sign informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose esomeprazole and amoxicillin dual therapy	Esomeprazole	Esomeprazole 40 mg and amoxicillin 1000 mg by mouth，three time daily for 14 days
High-dose esomeprazole and amoxicillin dual therapy	Amoxicillin	Esomeprazole 40 mg and amoxicillin 1000 mg by mouth，three time daily for 14 days
Bismuth-containing quadruple therapy	Bismuth	Tetracycline 500mg three time daily for 14 days，furazolidone 100 mg, esomeprazole 40 mg, and Bismuth 220mg by mouth, twice daily for 14 days.
Bismuth-containing quadruple therapy	Furazolidone	Tetracycline 500mg three time daily for 14 days，furazolidone 100 mg, esomeprazole 40 mg, and Bismuth 220mg by mouth, twice daily for 14 days.
Bismuth-containing quadruple therapy	Esomeprazole	Tetracycline 500mg three time daily for 14 days，furazolidone 100 mg, esomeprazole 40 mg, and Bismuth 220mg by mouth, twice daily for 14 days.
Bismuth-containing quadruple therapy	Tetracycline	Tetracycline 500mg three time daily for 14 days，furazolidone 100 mg, esomeprazole 40 mg, and Bismuth 220mg by mouth, twice daily for 14 days.

Primary Outcome Measures

Name	Time	Method
Helicobacter pylori eradication	28 days after treatment	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

Secondary Outcome Measures

Name	Time	Method
symptoms effective rates	14 days of treatment, and 28 days after treatment	symptoms improvement rates Evaluation improvement rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom improvement rate =#total score before treatment - total score after treatment#/total score before treatment x100%. Total score = frequency + severity.Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence, etc. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe
adverse events	14 days of treatment, and 28 days after treatment	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.

Trial Locations

Locations (1)

Xijing Hosipital of Digestive Disease; 🇨🇳 Xi'an, Shaanxi, China