Gastritis Associated With Helicobacter PyloriPhase 3NCT02827942
Comparison of Vonoprazan-based Dual and Triple Therapies for H. Pylori Eradication
A Phase 3 study testing vonoprazan 20 mg bid, Amoxicillin 500 mg tid and Amoxicillin 750 mg bid in people with Gastritis Associated With Helicobacter Pylori, run by Hamamatsu University at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Gastritis Associated With Helicobacter Pylori
- What is being tested?
- vonoprazan 20 mg bid, Amoxicillin 500 mg tid and Amoxicillin 750 mg bid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteJapan
- Study dates
- 1 Jul 2016to 31 Mar 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Japan1 site
Hamamatsu University School of Medicine
Hamamatsu, Shizuoka, 431-3192
About this study
Official title: Comparison of Dual Amoxicillin/Vonoprazan Therapy and Triple Vonoprazan/Amoxicillin/Clarithromycin or Metronidazole Therapy for H. Pylori Eradication
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.
Read the 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.
- Being tested
- vonoprazan 20 mg bid, Amoxicillin 500 mg tid, Amoxicillin 750 mg bid, Clarithromycin 200 mg bid, Metronidazole 250 mg bid
- Keywords
- pylori
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vonoprazan 20 mg bidDrug
Also called takecab® 20 mg bid
Vonoprazan is potent acid inhibitor. Vonoprazan 20 mg is dosed twice daily for 1 week.
Amoxicillin 500 mg tidDrug
Also called Sawacillin® 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.
Amoxicillin 750 mg bidDrug
Also called Sawacillin® 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.
Clarithromycin 200 mg bidDrug
Also called Claris® 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.
Metronidazole 250 mg bidDrug
Also called fragile 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.
| Study group | Role | What they receive |
|---|---|---|
| Dual therapy | Experimental | 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. Receives: Drug: vonoprazan 20 mg bid; Drug: Amoxicillin 500 mg tid |
| Triple therapy | Active comparator | 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. Receives: Drug: vonoprazan 20 mg bid; Drug: Amoxicillin 750 mg bid; Drug: Clarithromycin 200 mg bid; Drug: Metronidazole 250 mg bid |
What is being measured
The primary outcome is the main question the study is designed to answer.
The success or failure of eradication
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.
Measured: 4 to 8 weeks after the end of the eradication therapy
Secondary outcomes (1)
Adverse events
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start1 Jul 2016
- Primary completion31 Dec 2018
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastritis Associated With Helicobacter PyloriStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of the dual VPZ/AMPC therapy and triple VPZ/AMPC/CAM therapy
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamamatsu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Takahisa Furuta, Hamamatsu University
- Investigators
- Takahisa Furuta, MD, PhD, Study chair, Hamamatsu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827942
- Sponsor's protocol ID
- R15-006
- Status last verified
- Apr 2019
- First submitted
- 12 Jun 2016
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: The individual data cannot be taken out from the hospital without permission.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Dual Amoxicillin/Vonoprazan Therapy and Triple Vonoprazan/Amoxicillin/Clarithromycin or Metronidazole Therapy for H. Pylori Eradication
- ClinicalTrials.gov ID
- NCT02827942
- Acronym / sponsor ID
- R15-006
- Keywords
- pylori
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Hamamatsu UniversityUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Comparison of the dual VPZ/AMPC therapy and triple VPZ/AMPC/CAM therapy
| Arm | Type | Receives |
|---|---|---|
| Dual therapy | Experimental | Drug: vonoprazan 20 mg bid, Drug: Amoxicillin 500 mg tidPatients 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. |
| Triple therapy | Active comparator | Drug: vonoprazan 20 mg bid, Drug: Amoxicillin 750 mg bid, Drug: Clarithromycin 200 mg bid, Drug: Metronidazole 250 mg bidPatients 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. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| vonoprazan 20 mg bidAlso: takecab® 20 mg bidVonoprazan is potent acid inhibitor. Vonoprazan 20 mg is dosed twice daily for 1 week. | Drug | Dual therapy, Triple therapy |
| Amoxicillin 500 mg tidAlso: Sawacillin® 500 mg tidAmoxicillin is antibiotics. Its bactericidal effect is time-dependent. Then, 500 mg of amoxicillin is dosed three times daily for 1 week. | Drug | Dual therapy |
| Amoxicillin 750 mg bidAlso: Sawacillin® 750 mg bidAmoxicillin 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. | Drug | Triple therapy |
| Clarithromycin 200 mg bidAlso: Claris® 200 mg bidClarithromycin 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. | Drug | Triple therapy |
| Metronidazole 250 mg bidAlso: fragile 250 mg bidMetronidazole 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. | Drug | Triple therapy |
Primary outcome
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.
1 secondary outcome
Adverse events
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Individual participant dataSharing planned: No. The individual data cannot be taken out from the hospital without permission.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takahisa Furuta, MD, PhD study chair
Hamamatsu University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vonoprazan 20 mg bid, Amoxicillin 500 mg tid and Amoxicillin 750 mg bid in people with Gastritis Associated With Helicobacter Pylori, run by Hamamatsu University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success or failure of eradication (time frame: 4 to 8 weeks after the end of the eradication therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2019.