UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017891 |
|---|---|
| Receipt number | R000020727 |
| Scientific Title | Efficacy of triple therapy for Helicobacter pylori infection using amoxicillin and clarithromycin and TAK-438 (vonoprazan) which is a novel potassium-competitive acid blocker to the patients treated unsuccessfully with PPI, amoxicillin and clarithromycin. |
| Date of disclosure of the study information | 2015/06/12 |
| Last modified on | 2016/01/27 16:07:21 |
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Basic information
Public title
Efficacy of triple therapy for Helicobacter pylori infection using amoxicillin and clarithromycin and TAK-438 (vonoprazan) which is a novel potassium-competitive acid blocker to the patients treated unsuccessfully with PPI, amoxicillin and clarithromycin.
Acronym
Efficacy of the treatment with TAK-438 (vonoprazan)/AC regimen for Helicobacter pylori infection to the patients treated unsuccessfully with PPI/AC regimen.
Scientific Title
Efficacy of triple therapy for Helicobacter pylori infection using amoxicillin and clarithromycin and TAK-438 (vonoprazan) which is a novel potassium-competitive acid blocker to the patients treated unsuccessfully with PPI, amoxicillin and clarithromycin.
Scientific Title:Acronym
Efficacy of the treatment with TAK-438 (vonoprazan)/AC regimen for Helicobacter pylori infection to the patients treated unsuccessfully with PPI/AC regimen.
Region
| Japan |
Condition
Condition
Chronic gastritis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the new regimens for the eradication of Helicobacter pylori
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Eradication rate of TAK-438 (vonoprazan)/AC regimen. ITP and PP analysis
Key secondary outcomes
adverse events of TAK-438 (vonoprazan)/AC regimen
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with chronic gastritis who visited the outpatient clinic of Kagawa Prefectural Central Hospital or Fukuyama medical centre, and were found to be H. pylori-positive.
Key exclusion criteria
We excluded patients if they had previously undergone treatment for eradication of H. pylori or gastrectomy; were pregnant; had an allergy to penicillin; had used a PPI, H2 receptor antagonist, adrenocortical steroids, or non-steroidal anti-inflammatory drugs within the month preceding the study.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoki Inaba |
Organization
Kagawa Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
Takamatsu, Kagawa, Japan
TEL
(+81)-87-811-3333
t-inaba@chp-kagawa.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoki Inaba |
Organization
Kagawa Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
Takamatsu, Kagawa, Japan
TEL
(+81)-87-811-3333
Homepage URL
t-inaba@chp-kagawa.jp
Sponsor or person
Institute
Kagawa Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
香川県立中央病院 （香川県）、福山医療センター（広島県）、岡山大学病院 （岡山県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Finally, the eradication rate of H. pylori was 70.2% with a second-line regimen of TAK-438AC in patients for whom the firrst-line treatment with RAC failed. Our study shows promising results of H. pylori eradication with TAK-438-based triple therapy after proton pump inhibitor-based triple therapy failure, based on faster onset of increase in intragastric pH by TAK-438 (vonoprazan).
Aliment Pharmacol Ther 2016; 43: 166
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 01 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No problem of safty
Management information
Registered date
| 2015 | Year | 06 | Month | 12 | Day |
Last modified on
| 2016 | Year | 01 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020727
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