- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02296021
Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Bismuth-containing Quadruple Therapy
Helicobacter Pylori Eradication With Berberine Hydrochloride,Esomeprazole,Amoxicillin and Clarithromycin Versus Bismuth,Esomeprazole,Amoxicillin,and Clarithromycin: a Randomized,Open-label, Non-inferiority, Phase Ⅳ Trail
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 28 days and subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath 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 12 and 14.
Follow-up: includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
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Shanxi
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Xi'an, Shanxi, China, 710032
- Xijing Hospital of Digestive Diseases
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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.
- Patients are willing to receive eradication treatment.
- 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 antibiotics to eradicate adequately recorded 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 Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
- Evidence of bleeding or iron eficiency 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).
- Enrolled in other clinical trials in the past 3 months.
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 quadruple therapy
Berberine 500 mg, esomeprazole 20 mg,amoxicillin 1000 mg, and clarithromycin 500 mg by mouth, twice daily for 14 days.
|
Berberine-containing quadruple therapy group: given for 14 days at a dose of berberine 100 mg 5 tablets BID, esomeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
Esmeprazole 20mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.
Other Names:
Amoxicillin 500 mg 2 capsules BID plus esmeprazole 20mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.
Other Names:
Clarithromycin 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, esmeprazole 20mg 1tablet BID, and colloidal bismuth tartrate capsule55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.
|
Active Comparator: bismuth quadruple therapy
Bismuth 220 mg, esomeprazole 20 mg, amoxicillin 1000 mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
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Esmeprazole 20mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.
Other Names:
Amoxicillin 500 mg 2 capsules BID plus esmeprazole 20mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.
Other Names:
Clarithromycin 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, esmeprazole 20mg 1tablet BID, and colloidal bismuth tartrate capsule55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.
Bismuth-containing quadruple therapy group: given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 28 days after the end of eradication.
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28 days after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
symptoms effective rates
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
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adverse events
Time Frame: 14 days of treatment, and 28 days after treatment
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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.
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14 days of treatment, and 28 days after treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Yongquan Shi, Ph. D, Xijing Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Signs and Symptoms, Digestive
- Gastrointestinal Diseases
- Stomach Diseases
- Gastroenteritis
- Intestinal Diseases
- Duodenal Diseases
- Gastritis
- Dyspepsia
- Peptic Ulcer
- 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
- Amoxicillin
- Clarithromycin
- Esomeprazole
- Bismuth
Other Study ID Numbers
- KY20140916-2
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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