UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016335 |
|---|---|
| Receipt number | R000018955 |
| Scientific Title | PCAB-based H.pylori eradication study for patients with penicillin allergy |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2020/03/18 17:09:21 |
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Basic information
Public title
PCAB-based H.pylori eradication study for patients with penicillin allergy
Acronym
PCAB-based H.pylori eradication study for patients with penicillin allergy (CAP-pen study)
Scientific Title
PCAB-based H.pylori eradication study for patients with penicillin allergy
Scientific Title:Acronym
PCAB-based H.pylori eradication study for patients with penicillin allergy (CAP-pen study)
Region
| Japan |
Condition
Condition
Helicobacter pylori infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of P-CAB as first and second line H.pylori eradication for patients with penicillin allergy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The H.pylori eradication rate of Clarithromycin(CAM) + metronidazole(MNZ) + P-CAB (first line) and metronidazole(MNZ) + sitafloxacin(STFX) + P-CAB (second line) for patients with penicillin allergy.
Key secondary outcomes
To evaluate the safety of the two regimens for patients with penicillin allergy.
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
Clarithromycin(CAM) + metronidazole(MNZ) + P-CAB
(first line eradication)
Metronidazole(MNZ) + sitafloxacin (STFX) + P-CAB
(second line eradication)
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
Penicillin allergic patients with H.pylori infection who want to take eradication treatment. Patients who give a written informed consent.
Key exclusion criteria
Past history of taking second line H.pylori eradication therapy. Pregnancy or lactation. Past history of allergy for the drugs used in this therapy. Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction. Patients who are disqualified for the study by physicians.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Maeda |
Organization
Yokohama City University Hospital
Division name
Gastroenterology
Zip code
236-0004
Address
Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL
045-261-5656
smaeda@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Soichiro |
| Middle name | |
| Last name | Sue |
Organization
Yokohama City University Hospital
Division name
Gastroenterology
Zip code
236-0004
Address
Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL
045-261-5656
Homepage URL
ssue@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University(Basic research expenditures)
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The Institute for Adult Diseases, Asahi Life Foundation
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Certified Institutional Review Board
Address
Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa
Tel
045-370-7627
ycu_crb@yokohama-cu.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
横浜市立大学付属病院（神奈川県） Yokohama City University Hospital
(kanagawa)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://jrct.niph.go.jp/latest-detail/jRCTs031180133
Number of participants that the trial has enrolled
60
Results
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 | 15 | Day |
Date of IRB
| 2015 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 26 | Day |
Last modified on
| 2020 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018955
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
