- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05014334
Study on The Efficacy and Safety of Berberine-containing Triple Therapy in Helicobacter Pylori First-Line Eradication
Study on The Efficacy and Safety of Berberine,Amoxicillin and Vonoprazan Containing Triple Therapy in Helicobacter Pylori First-Line Eradication
Study Overview
Status
Conditions
Intervention / Treatment
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 13 and 17.
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Yongquan Shi, Ph. D
- Phone Number: 86-29-84771515
- Email: shiyquan@fmmu.edu.cn
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710032
- Recruiting
- Xijing Hosipital of Digestive Disease
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 18~70,both gender.
- Patients with upper gastrointestinal symptoms and with documented H.pylori infection who did not receive Helicobacter pylori eradication treatment;
- Patients are willing to receive eradication treatment.
- Women of childbearing age were required to use medically acceptable contraceptive methods during and 30 days after the trial.
Exclusion Criteria:
- Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
- Patients with contraindications or allergies to the study drug.
- Severe organ damage and complications (such as liver cirrhosis, uremia, etc.), severe or unstable cardiopulmonary or endocrine diseases.
- 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).
- Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
- Pregnant or lactating women.
- Underwent upper gastrointestinal Surgery.
- Patients with moderate to severe dysplasia or high degree of intraepithelial neoplasia.
- Patients 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).
- Patients who has psychological problem or poor compliance.
- Enrolled in other clinical trials in the past 3 months.
- Refuse to sign informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Berberine-containing triple therapy
vonoprazan 20 mg , amoxicillin 1000 mg , and berberine 500 mg by mouth,twice daily for 14 days.
|
berberine 500 mg, twice daily for 14 days
Vonoprazan 20 mg, twice daily for 14 days
amoxicillin 1000mg, twice daily for 14 days.
|
Active Comparator: Bismuth-containing quadruple therapy
Bismuth potassium citrate 220 mg,rabeprazole 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
|
amoxicillin 1000mg, twice daily for 14 days.
Rabeprazole 10mg, twice daily for 14 days.
Bismuth 220mg, twice daily for 14 days.
clarithromy 500mg, twice daily for 14 days.
|
Active Comparator: vonoprazan-containing quadruple therapy
Bismuth potassium citrate 220 mg, vonoprazan 10 mg, amoxicillin 1000mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
|
Vonoprazan 20 mg, twice daily for 14 days
amoxicillin 1000mg, twice daily for 14 days.
Bismuth 220mg, twice daily for 14 days.
clarithromy 500mg, twice daily for 14 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
H pylori eradication rates
Time Frame: 28 days after treatment
|
The primary end point of this study is H.pylori eradication,established by negative urea breath test,rapid urease test or helicobacter pylori stool antigen test 28 days after the end of treatment.
|
28 days after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
14 days of treatment, and 28 days after treatment
|
symptoms effective rate
Time Frame: 14 days of treatment, and 28 days after treatment
|
Evaluation effective rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom effective rate =(total score before treatment - total score after treatment)/total score before treatment x 100%. Total score = frequency + severity. Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence. 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
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Gastritis
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Gastrointestinal Agents
- Anti-Bacterial Agents
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Protein Synthesis Inhibitors
- Anti-Ulcer Agents
- Proton Pump Inhibitors
- Antacids
- Rabeprazole
- Amoxicillin
- Clarithromycin
- Bismuth
Other Study ID Numbers
- KY20212155-C-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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