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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 : Unknown
Verified July 2016 by Takahisa Furuta, Hamamatsu University.
Recruitment status was:  Not yet recruiting
First Posted : July 11, 2016
Last Update Posted : July 11, 2016
Sponsor:
Information provided by (Responsible Party):
Takahisa Furuta, Hamamatsu University

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.

Condition or disease Intervention/treatment Phase
Gastritis Associated With Helicobacter Pylori Drug: vonoprazan 20 mg bid Drug: Amoxicillin 500 mg tid Drug: Amoxicillin 750 mg bid Drug: Clarithromycin 200 mg bid Drug: Metronidazole 250 mg bid Phase 3

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Dual Amoxicillin/Vonoprazan Therapy and Triple Vonoprazan/Amoxicillin/Clarithromycin or Metronidazole Therapy for H. Pylori Eradication
Study Start Date : July 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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

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.
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 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02827942


Contacts
Contact: Takahisa Furuta, MD PhD +81-53-435-2850 furuta@hama-med.ac.jp
Contact: Takuma Kagami, MD +81-53-435-2261 D14029@hama-med.ac.jp

Locations
Japan
Hamamatsu University School of Medicine Not yet recruiting
Hamamatsu, Shizuoka, Japan, 431-3192
Contact: Takahisa Furuta, MD, PhD    81-53-435-2850    furuta@hama-med.ac.jp   
Principal Investigator: Takahisa Furuta, MD, PhD         
Sponsors and Collaborators
Hamamatsu University
Investigators
Study Chair: Takahisa Furuta, MD, PhD Hamamatsu University

Responsible Party: Takahisa Furuta, Professor, Hamamatsu University
ClinicalTrials.gov Identifier: NCT02827942     History of Changes
Other Study ID Numbers: R15-006
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The individual data cannot be taken out from the hospital without permission.

Keywords provided by Takahisa Furuta, Hamamatsu University:
pylori

Additional relevant MeSH terms:
Gastritis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Stomach Diseases
Amoxicillin
Clarithromycin
Metronidazole
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors