Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 64 of 398 for:    CLARITHROMYCIN

Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Clarithromycin Quadruple Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02633930
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : January 18, 2017
Sponsor:
Information provided by (Responsible Party):
Yongquan Shi, Xijing Hospital of Digestive Diseases

Tracking Information
First Submitted Date  ICMJE December 15, 2015
First Posted Date  ICMJE December 17, 2015
Last Update Posted Date January 18, 2017
Study Start Date  ICMJE December 2015
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02633930 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2015)
  • 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
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Helicobacter Pylori Eradication With Berberine Quadruple Therapy Versus Clarithromycin Quadruple Therapy
Official Title  ICMJE Helicobacter Pylori Eradication With Berberine Hydrochloride, Lansoprazole, Amoxicillin and Bismuth Versus Clarithromycin Bismuth, Lansoprazole and Amoxicillin: A Randomized, Open-label, Non-inferiority, Phase Ⅳ Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Gastritis
  • Peptic Ulcer
  • Dyspepsia
Intervention  ICMJE
  • Drug: Berberine
    : 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
  • Drug: clarithromycin
    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.
  • Drug: Bismuth
    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
    Other Name: Bitnal
  • Drug: Lansoprazole
    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
    Other Name: Takepron
  • Drug: amoxicillin
    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.
    Other Name: Amoxy ( Uni-Amocin )
Study Arms  ICMJE
  • Experimental: berberine quadruple therapy
    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.
    Interventions:
    • Drug: Berberine
    • Drug: Bismuth
    • Drug: Lansoprazole
    • Drug: amoxicillin
  • Active Comparator: clarithromycin quadruple therapy
    Bismuth 220 mg, lansoprazole30 mg, amoxicillin 1000 mg, and clarithromycin 500 mg by mouth,twice daily for 14 days.
    Interventions:
    • Drug: clarithromycin
    • Drug: Bismuth
    • Drug: Lansoprazole
    • Drug: amoxicillin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 16, 2015)
566
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age between 18~70,both gender.
  2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
  3. Patients are willing to receive eradication treatment.
  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 antibiotics to eradicate adequately recorded 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 Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
  8. Evidence of bleeding or iron efficiency anemia.
  9. A history of malignancy.
  10. Drug or alcohol abuse history in the past 1 year.
  11. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
  12. Enrolled in other clinical trials in the past 3 months.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02633930
Other Study ID Numbers  ICMJE KY20151203-2
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Yongquan Shi, Xijing Hospital of Digestive Diseases
Study Sponsor  ICMJE Xijing Hospital of Digestive Diseases
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Yongquan Shi, Ph. D Xijing Hospital
PRS Account Xijing Hospital of Digestive Diseases
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP