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Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication

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ClinicalTrials.gov Identifier: NCT02827942
Recruitment Status : Completed
First Posted : July 11, 2016
Last Update Posted : April 9, 2019
Sponsor:
Information provided by (Responsible Party):
Takahisa Furuta, Hamamatsu University

Tracking Information
First Submitted Date  ICMJE June 12, 2016
First Posted Date  ICMJE July 11, 2016
Last Update Posted Date April 9, 2019
Actual Study Start Date  ICMJE July 1, 2016
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
The success or failure of eradication [ Time Frame: 4 to 8 weeks after the end of the eradication therapy ]
Success or failure of eradication of H. pylor is to be diagnosed at 4 to 8 weeks after the end of the eradication therapy by13C-urea breath test.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 6, 2016)
Adverse events [ Time Frame: 1 week ]
Adverse events related that happen during 1 week-treatments, such as diarrhea, loose stool, abdominal pain, and allergic reaction are checked by interview when patients visit the hospital to undergo the 13C-urea breath test for the diagnosis of success or failure of eradication of H. pylori.
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 Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication
Official Title  ICMJE Comparison of Dual Amoxicillin/Vonoprazan Therapy and Triple Vonoprazan/Amoxicillin/Clarithromycin or Metronidazole Therapy for H. Pylori Eradication
Brief Summary Patients infected with H. pylori were randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg or metronidazole 250 mg bid bid for 1 week. Success or failure of eradication was determined by the 13C-urea breath test performed at 1 month after the therapy.
Detailed Description

Patients infected with H. pylori were enrolled and invited to the study.

Patients who have never undergone the H. pylori eradication therapy are randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and clarithromycin 200 mg bid for 1 week.

Patients who have ever failed in the eradication of H. pylori by the triple therapy containing clarithromycin are randomly assigned to the dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week or the triple therapy with vonoprazan 20 mg bid, amoxicillin 750 mg bid and metronidazole 250 mg bid for 1 week.

Success or failure of eradication was determined by the 13C-urea breath test performed at 1 month after the therapy.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Comparison of the dual VPZ/AMPC therapy and triple VPZ/AMPC/CAM therapy
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastritis Associated With Helicobacter Pylori
Intervention  ICMJE
  • Drug: vonoprazan 20 mg bid
    Vonoprazan is potent acid inhibitor. Vonoprazan 20 mg is dosed twice daily for 1 week.
    Other Name: takecab® 20 mg bid
  • Drug: Amoxicillin 500 mg tid
    Amoxicillin is antibiotics. Its bactericidal effect is time-dependent. Then, 500 mg of amoxicillin is dosed three times daily for 1 week.
    Other Name: Sawacillin® 500 mg tid
  • Drug: Amoxicillin 750 mg bid
    Amoxicillin is antibiotics. Its bactericidal effect is time-dependent. However, the standard regimen in Japan, 750 mg of amoxicillin is dosed twice daily with clarithromycin or metronidazole for 1 week. Then, 750 mg of amoxicillin is dosed twice daily.
    Other Name: Sawacillin® 750 mg bid
  • Drug: Clarithromycin 200 mg bid
    Clarithromycin is antibiotics. It is involved in the standard first line regimen in Japan. Then, 200 mg of clarithromycin is dosed twice daily for 1 week.
    Other Name: Claris® 200 mg bid
  • Drug: Metronidazole 250 mg bid
    Metronidazole is antimicrobial agent. It is involved in the standard second line regimen in Japan. Then, 250 mg of metronidazole is dosed twice daily for 1 week.
    Other Name: fragile 250 mg bid
Study Arms  ICMJE
  • Experimental: Dual therapy
    Patients assigned to this group are treated with dual therapy with vonoprazan 20 mg bid and amoxicillin 500 mg tid for 1 week. The eradication rate attained with this regimen is measured.
    Interventions:
    • Drug: vonoprazan 20 mg bid
    • Drug: Amoxicillin 500 mg tid
  • Active Comparator: Triple therapy
    Patients assigned to this group are treated with the triple therapy with vonoprazan 20 mg bid, clarithromycin 200 mg bid and amoxicillin 750 mg bid for 1 week as the first line therapy or the triple therapy with vonoprazan 20 mg bid, metronidazole 250 mg bid and amoxicillin 750 mg bid for 1 week as the second line therapy. The eradication rates attained with these regimens are measured.
    Interventions:
    • Drug: vonoprazan 20 mg bid
    • Drug: Amoxicillin 750 mg bid
    • Drug: Clarithromycin 200 mg bid
    • Drug: Metronidazole 250 mg bid
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: April 7, 2019)
112
Original Estimated Enrollment  ICMJE
 (submitted: July 6, 2016)
100
Actual Study Completion Date  ICMJE March 31, 2019
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients infected with H. pylori
  • Patients who are not allergic to any of drugs used in this study
  • Patients who agree to participate to the study patients who are treatment naive for eradication of H. pylori

Exclusion Criteria:

  • Patients not infected with H. pylori
  • Patients who are allergic to any of drugs used in this study
  • Patients who do not agree to participate to the study
  • Severe general condition, such as renal insufficiency or liver dysfunction
  • History of gastrectomy
  • Inability to undergo eradication therapy
  • Patients who have ever undergone the eradication therapy for H. pylori infection
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 90 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 Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02827942
Other Study ID Numbers  ICMJE R15-006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The individual data cannot be taken out from the hospital without permission.
Responsible Party Takahisa Furuta, Hamamatsu University
Study Sponsor  ICMJE Hamamatsu University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Takahisa Furuta, MD, PhD Hamamatsu University
PRS Account Hamamatsu University
Verification Date April 2019

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