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NCT Number: NCT04678492

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

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.

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Key information

Conditions

Gastritis Digestive System Diseases Digestive System Neoplasms Duodenal Diseases Dyspepsia Gastric Cancer Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Helicobacter Pylori Infection Intestinal Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Peptic Ulcer Signs and Symptoms Signs and Symptoms, Digestive Stomach Diseases Stomach Neoplasms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Xijing Hosipital of Digestive Disease

Xi'an, Shaanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Nexium

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

Other names: Amoxy

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

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

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

Primary outcomes

  1. Helicobacter pylori eradication

    Time frame: 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 outcomes

  1. symptoms effective rates

    Time frame: 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

  2. adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 22, 2020
Registry last updated
Jan 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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