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

Primary Purpose

Gastritis, Dyspepsia, Helicobacter Pylori Infection

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Esomeprazole

Amoxicillin

Bismuth

Esomeprazole

Tetracycline

Furazolidone

About this trial

This is an interventional treatment trial for Gastritis focused on measuring Helicobacter pylori, High-dose dual therapy, Bismuth-combining quadruple therapy

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients who had failed H.pylori eradication therapies before.
Age between 18~70, both gender.
Patients who had failed H.pylori eradication therapies during last 2 years and stop the eradication therapies for at least 3 months.
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:

Patients are excluded if they have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori.
Contraindications to study drugs.
Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
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).
Pregnant or lactating women.
Underwent upper gastrointestinal Surgery.
Patients with moderate or severe atypical hyperplasia or high-grade intraepithelial neoplasia.
have symptom of dysphagia.
Evidence of bleeding or iron efficiency anemia.
A history of malignancy.
Drug or alcohol abuse history in the past 1 year.
Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
a person with a mental disorder.
Enrolled in other clinical trials in the past 3 months.
Refuse to sign informed consent.

Sites / Locations

Xijing Hosipital of Digestive Disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

High-dose esomeprazole and amoxicillin dual therapy

Bismuth-containing quadruple therapy

Arm Description

Esomeprazole 40 mg and amoxicillin 1000 mg by mouth，three time daily for 14 days

Tetracycline 500mg three time daily for 14 days，furazolidone 100 mg, esomeprazole 40 mg, and Bismuth 220mg by mouth, twice daily for 14 days.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT04678492

First Posted

December 13, 2020

Last Updated

January 29, 2023

Sponsor

Xijing Hospital of Digestive Diseases

1. Study Identification

Unique Protocol Identification Number

NCT04678492

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

December 20, 2020 (Actual)

Primary Completion Date

December 20, 2021 (Actual)

Study Completion Date

December 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Xijing Hospital of Digestive Diseases

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Helicobacter pylori, High-dose dual therapy, Bismuth-combining quadruple therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

658 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High-dose esomeprazole and amoxicillin dual therapy

Arm Type

Experimental

Arm Description

Esomeprazole 40 mg and amoxicillin 1000 mg by mouth，three time daily for 14 days

Arm Title

Bismuth-containing quadruple therapy

Arm Type

Active Comparator

Arm Description

Tetracycline 500mg three time daily for 14 days，furazolidone 100 mg, esomeprazole 40 mg, and Bismuth 220mg by mouth, twice daily for 14 days.

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Other Intervention Name(s)

Nexium

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Amoxicillin

Other Intervention Name(s)

Amoxy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Bismuth

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Esomeprazole

Other Intervention Name(s)

Nexium

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Tetracycline

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Furazolidone

Intervention Description

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

Primary Outcome Measure Information:

Title

Helicobacter pylori eradication

Description

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

Secondary Outcome Measure Information:

Title

symptoms effective rates

Description

Time Frame

14 days of treatment, and 28 days after treatment

Title

adverse events

Description

Time Frame

14 days of treatment, and 28 days after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who had failed H.pylori eradication therapies before. Age between 18~70, both gender. Patients who had failed H.pylori eradication therapies during last 2 years and stop the eradication therapies for at least 3 months. 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: Patients are excluded if they have previously used tetracycline and furazolidone antibiotics to eradicate infection with H. pylori. Contraindications to study drugs. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease. 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). Pregnant or lactating women. Underwent upper gastrointestinal Surgery. Patients with moderate or severe atypical hyperplasia or high-grade intraepithelial neoplasia. have symptom of dysphagia. Evidence of bleeding or iron efficiency anemia. A history of malignancy. Drug or alcohol abuse history in the past 1 year. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d). a person with a mental disorder. Enrolled in other clinical trials in the past 3 months. Refuse to sign informed consent.

Facility Information:

Facility Name

Xijing Hosipital of Digestive Disease

City

Xi'an

State/Province

Shaanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36193978

Citation

Bi H, Chen X, Chen Y, Zhao X, Wang S, Wang J, Lyu T, Han S, Lin T, Li M, Yuan D, Liu J, Shi Y. Efficacy and safety of high-dose esomeprazole-amoxicillin dual therapy for Helicobacter pylori rescue treatment: a multicenter, prospective, randomized, controlled trial. Chin Med J (Engl). 2022 Jul 20;135(14):1707-1715. doi: 10.1097/CM9.0000000000002289.

Results Reference

derived

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

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