Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Clarithromycin Quadruple Therapy

NCT02633930 | Completed Phase 4 DMC

• 1 other identifier: KY20151203-2
• Study Type: interventional
• Target: 566
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims at evaluating efficacy and safety of berberine-containing quadruple therapy(berberine, lansoprazole, bismuth and amoxicillin) versus clarithromycin-containing quadruple therapy (clarithromycin,lansoprazole, bismuth and amoxicillin) in H. pylori eradication. It is hypothesized that berberine-containing quadruple therapy is non-inferior to clarithromycin-containing quadruple therapy. Patients with confirmed H. pylori positive status will be randomized to one of the treatments described above. At week 2 and 6 follow-up visits, a urea breath test(UBT) will be performed to confirm eradication.

Conditions

Gastritis; Peptic Ulcer; Dyspepsia

Keywords

helicobacter pylori; berberine-containing quadruple therapy; clarithromycin-containing 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 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)

berberine quadruple therapy

EXPERIMENTAL

Berberine 300 mg, three times daily for 14 days,lansoprazole 30 mg,amoxicillin 1000 mg, and Bismuth 220 mg by mouth, twice daily for 14 days.

Drug: Berberine; Drug: Bismuth; Drug: Lansoprazole; Drug: amoxicillin

clarithromycin quadruple therapy

ACTIVE COMPARATOR

Bismuth 220 mg, lansoprazole30 mg, amoxicillin 1000 mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.

Drug: clarithromycin; Drug: Bismuth; Drug: Lansoprazole; Drug: amoxicillin

Interventions

Berberine DRUG

: given for 14 days at a dose of berberine 100 mg 3 tablets TID, lansoprazole 30 mg BID, amoxicillin 500 mg 2 capsules BID, and colloidal bismuth tartrate capsule55 mg 4 capsules BID

berberine quadruple therapy

clarithromycin DRUG

Clarithromycin-containing quadruple therapy group 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, lansoprazole 30mg 1tablet BID, and colloidal bismuth tartrate capsule55 mg 4 capsules BID.

clarithromycin quadruple therapy

Bismuth DRUG

Bismuth:given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, lansoprazole30 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID or given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, lansoprazole30 mg BID, amoxicillin 500 mg 2 capsules BID, and berberine 100 mg 3 tablet TID

Also known as: Bitnal

berberine quadruple therapy; clarithromycin quadruple therapy

Lansoprazole DRUG

Lansoprazole 30mg 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 3 tablets TID given to berberine-containing quadruple therapy group or clarithromycin-containing quadruple therapy group

Also known as: Takepron

berberine quadruple therapy; clarithromycin quadruple therapy

amoxicillin DRUG

Amoxicillin 500 mg 2 capsules BID plus lansoprazole 30mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 3 tablets TID as a dose given for clarithromycin-containing quadruple therapy or berberine-containing quadruple therapy.

Also known as: Amoxy ( Uni-Amocin )

berberine quadruple therapy; clarithromycin 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:

• 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.

You may not qualify if:

• 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 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).
• Enrolled in other clinical trials in the past 3 months.

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (2)

Xijing Hospital of Digestive Diseases

Xi’an, Shanxi, 710032, China

Location

Xijing Hospital of Digestive Disease

Xi’an, Shanxi, 710032, China

Location

MeSH Terms

Conditions

Gastritis; Peptic Ulcer; Dyspepsia

Interventions

Berberine; Clarithromycin; Bismuth; Lansoprazole; Amoxicillin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Berberine Alkaloids; Benzylisoquinolines; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Elements, Radioactive; Elements; Inorganic Chemicals; Metals, Heavy; Radioisotopes; Isotopes; Metals; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Officials

• Yongquan Shi, Ph. D

  Xijing Hospital

  PRINCIPAL INVESTIGATOR

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: Doctor of Xijing Hospital of Digestive Diseases,Principal investagator,Clinical professor

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: December 17, 2015
• Study Start: December 1, 2015
• Primary Completion: June 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)