UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021928 |
|---|---|
| Receipt number | R000025282 |
| Scientific Title | The efficacy of third or fourth line H. pylori eradication therapy with refabutin-amoxicillin-vonaprazan 7day regimen |
| Date of disclosure of the study information | 2016/04/15 |
| Last modified on | 2023/03/11 10:09:18 |
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Basic information
Public title
The efficacy of third or fourth line H. pylori eradication therapy with refabutin-amoxicillin-vonaprazan 7day regimen
Acronym
The efficacy of third or fourth line H. pylori eradication therapy with refabutin-amoxicillin-vonaprazan 7day regimen
Scientific Title
The efficacy of third or fourth line H. pylori eradication therapy with refabutin-amoxicillin-vonaprazan 7day regimen
Scientific Title:Acronym
The efficacy of third or fourth line H. pylori eradication therapy with refabutin-amoxicillin-vonaprazan 7day regimen
Region
| Japan |
Condition
Condition
H. pylori-positve patients after the 2nd line eradication failure
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of 7-day regimen with RBT, AMPC and Pcab.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of H. pylori eradication
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
vonoprazan 40mg, b.i.d., amoxicillin 2.0g, q.i.d., rifabutin 300mg, o.d.
7 days
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
H. pylori-positve patients after the 2nd line H. pylori eradication therapy with informed consent
Key exclusion criteria
1. Patients with allergy for rifamycins
2. Patients with past histry of tuberculosis or nontuberculous mycobacterial infection
3. Patients with allergy for PPIs
4. Patients with allergy for penicillin
5. Patients with severe liver injury and/or severe renal damage
6. Pregnancy or possible pregnancy
7. Patients who are taking voriconazole
8. Patients with uveitis
9. Patients who were recognized as inappropriate for entry
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tastuhiro |
| Middle name | |
| Last name | Masaoka |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-0016
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
TEL
03-5363-3790
masaoka@z6.keio.jp
Public contact
Name of contact person
| 1st name | Tastuhiro |
| Middle name | |
| Last name | Masaoka |
Organization
Keio University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
160-0016
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
TEL
03-5363-3790
Homepage URL
masaoka@z6.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
other
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Planning and Management Office Clinical and Translational Research Center.
Address
35 Shinanomachi, SHinjuku-ku, Tokyo
Tel
03-5363-3961
pmo@ccr.med.keio.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 15 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/35644041/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35644041/
Number of participants that the trial has enrolled
66
Results
Intention-to-treat and per-protocol analyses showed that our regimen resulted in a high eradication rate (91.2%, 95% CI: 84%-99% and 92.7%, 95% CI: 86%-100%, respectively). Adverse events occurred in 31.6% of the patients, and two patients discontinued the therapy.
Results date posted
| 2023 | Year | 03 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who did not respond to second-line therapy were enrolled. After H. pylori infection was confirmed with the culture method, the patients received rifabutin-containing triple therapy (20 mg vonoprazan b.i.d., 500 mg amoxicillin q.i.d., and 150 mg rifabutin q.d.) for 7 days.
Participant flow
Patients who did not respond to second-line therapy were enrolled. After H. pylori infection was confirmed with the culture method, the patients received rifabutin-containing triple therapy (20 mg vonoprazan b.i.d., 500 mg amoxicillin q.i.d., and 150 mg rifabutin q.d.) for 7 days.
Adverse events
Adverse events occurred in 31.6% of the patients, and two patients discontinued the therapy.
Outcome measures
Twelve weeks after the eradication therapy, successful eradication was confirmed using a 13 C urea breath test or the H. pylori stool antigen test. The results obtained from our previous study that reported a 10-day or 14-day esomeprazole based rifabutin-containing triple therapy as a third- or fourth-line rescue therapy treated patients were used as historical control. We determined the minimum inhibitory concentrations of amoxicillin and rifabutin. We also evaluated whether the patients were positive for the mutation of the rpoB gene.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 02 | Month | 04 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 15 | Day |
Last modified on
| 2023 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025282
