UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016337 |
|---|---|
| Receipt number | R000018957 |
| Scientific Title | Randomized Controlled Trial for H.pylori first line eradication therapy considering clarithromycin resistance: PCAB vs PPI |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2019/04/19 15:31:36 |
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Basic information
Public title
Randomized Controlled Trial for H.pylori first line eradication therapy considering clarithromycin resistance: PCAB vs PPI
Acronym
PCAB-based H.pylori first line eradication study (CAP study)
Scientific Title
Randomized Controlled Trial for H.pylori first line eradication therapy considering clarithromycin resistance: PCAB vs PPI
Scientific Title:Acronym
PCAB-based H.pylori first line eradication study (CAP 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 of PCAB in Clarithromycin resistance H.pylori first line eradication, and the equivalence of PCAB and PPI in Clarithromycin non-resistance H.pylori first line eradication
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of the eradication rate of the two regimens, amocixillin(AMPC)+clarithromycin(CAM)+PPI vs AMPC+CAM+PCAB for first line.
Key secondary outcomes
Comparison of the safety of the two regimens, amocixillin(AMPC)+clarithromycin(CAM)+PPI vs AMPC+CAM+PCAB for first line.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
amoxicillin(AMPC)+clarithromycin(CAM)+PCAB
Interventions/Control_2
amoxicillin(AMPC)+clarithromycin(CAM)+PPI
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
Patients with H.pylori infection who want to take eradication treatment. Patients who give a written informed consent.
Patients who can assess Clarithromycin resistance of H.pylori.
Key exclusion criteria
Past history of taking 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
160
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
Yokosuka City Hospital, Yokohama Hodogaya Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Ethics Committee
Address
Fukuura 3-9, Kanazawa, Yokohama, Kanagawa, Japan
Tel
045-370-7627
rinri@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://onlinelibrary.wiley.com/doi/epdf/10.1111/hel.12456
Number of participants that the trial has enrolled
147
Results
The ITT and PP eradication rates(ER) of V-AC in the CAM-susceptible H.pylori-infected patients were 87.3% (95%CI: 75.5-94.7%) and 88.9% (77.4-95.8%). The respective ER of PPI-AC were 76.5% (62.5-87.2%) and 86.7% (73.2-94.9%). No significant difference was observed between the groups in ITT(P = .21) or PP (P = .77) analyses. The questionnaire scores did not differ significantly between the groups. Both the ITT and PP ER of V-AC in the CAM-resistant patients were 82.9% (67.9%- 92.8%).
Results date posted
| 2019 | Year | 04 | Month | 19 | Day |
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 | 01 | Month | 09 | Day |
Anticipated trial start date
| 2015 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 10 | 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
| 2015 | Year | 01 | Month | 26 | Day |
Last modified on
| 2019 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018957
