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

Gastric Cancer Clinical Trial

Official title:

Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of High-dose Esomeprazole and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04678492
• Other study ID #: KY20202114-F-1
• Status: Completed
• Phase: Phase 4
• Start date: December 20, 2020
• Est. completion date: December 20, 2021

Study information

• Verified date: January 2023
• Source: Xijing Hospital of Digestive Diseases
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 658
• Est. completion date: December 20, 2021
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dyspepsia
• Gastric Cancer
• Gastritis
• Helicobacter Pylori Infection
• Peptic Ulcer

Intervention

Drug:
• Esomeprazole
High-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet TID plus amoxicillin 500 mg 2 capsules TID
• Amoxicillin
High-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID plus esomeprazole 40mg 1 tablet TID
• Bismuth
Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 40 mg 1 tablets BID,tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID
• Esomeprazole
Bismuth-containing quadruple therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet BID plus bismuth 110 mg 2 capsules BID,tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID
• Tetracycline
Bismuth-containing quadruple therapy:given for 14 days at a dose of tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID,esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID
• Furazolidone
Bismuth-containing quadruple therapy:given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus tetracycline 250mg 2 capsules TID,esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID

Locations

Country	Name	City	State
China	Xijing Hosipital of Digestive Disease	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	28 days after treatment
Secondary	symptoms effective rates	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	14 days of treatment, and 28 days after treatment
Secondary	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.	14 days of treatment, and 28 days after treatment