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
Verified date | January 2023 |
Source | Xijing Hospital of Digestive Diseases |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
China | Xijing Hosipital of Digestive Disease | Xi'an | Shaanxi |
Lead Sponsor | Collaborator |
---|---|
Xijing Hospital of Digestive Diseases |
China,
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 |
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