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

NCT04678492 | Completed Phase 4

• 1 other identifier: KY20202114-F-1
• Study Type: interventional
• Target: 658
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• symptoms effective rates

  14 days of treatment, and 28 days after treatment

• adverse events

  14 days of treatment, and 28 days after treatment

Study Arms (2)

High-dose esomeprazole and amoxicillin dual therapy

EXPERIMENTAL

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

Drug: Esomeprazole; Drug: Amoxicillin

Bismuth-containing quadruple therapy

ACTIVE COMPARATOR

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

Drug: Bismuth; Drug: Esomeprazole; Drug: Tetracycline; Drug: Furazolidone

Interventions

Esomeprazole DRUG

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

Also known as: Nexium

High-dose esomeprazole and amoxicillin dual therapy

Amoxicillin DRUG

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

Also known as: Amoxy

High-dose esomeprazole and amoxicillin dual therapy

Bismuth DRUG

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

Bismuth-containing quadruple therapy

Tetracycline DRUG

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

Bismuth-containing quadruple therapy

Furazolidone DRUG

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

Bismuth-containing quadruple therapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (1)

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 36193978 DERIVED

MeSH Terms

Conditions

Gastritis; Dyspepsia; Stomach Neoplasms; Peptic Ulcer

Interventions

Esomeprazole; Amoxicillin; Bismuth; Tetracycline; Furazolidone

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Duodenal Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Nitrofurans; Nitro Compounds; Oxazolidinones; Oxazoles; Azoles; Furans

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 13, 2020
• First Posted: December 22, 2020
• Study Start: December 20, 2020
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: January 31, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)