UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000016337
Receipt No. 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 (Ver. 8)

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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
Last 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
Email smaeda@med.yokohama-cu.ac.jp

Public contact
1st 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
Email ssue@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018957