UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007154
Receipt No. R000008426
Scientific Title Open labelled trial of salvaged therapy for the patients who show resistance to 3rd line of Hp eradication therapy
Date of disclosure of the study information 2012/01/27
Last modified on 2014/01/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Open labelled trial of salvaged therapy for the patients who show resistance to 3rd line of Hp eradication therapy
Acronym salvaged therapy for the patients who show resistance to 3rd line of Hp eradication therapy
Scientific Title Open labelled trial of salvaged therapy for the patients who show resistance to 3rd line of Hp eradication therapy
Scientific Title:Acronym salvaged therapy for the patients who show resistance to 3rd line of Hp eradication therapy
Region
Japan

Condition
Condition Patinets who show resistance to 3rd line therapy
Classification by specialty
Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy and safety of salvaged therapy for the patients who show resistance to 3rd line Hp eradaiction therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Efficacy of Hp eradication
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design expanded access
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 PPI+AMPC+LVFX
Interventions/Control_2 PPI+AMPC
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patinets who show resistace to the 3rd line therapy
Key exclusion criteria Allergy for the drugs
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Arai
Organization Chiba University Hospital
Division name Gastroenterology
Zip code
Address 1-8-1 Inohana, Chuo-ku, Chiba City
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Chiba University Hospital
Division name gastroenterology
Zip code
Address
TEL 043-226-2083
Homepage URL
Email

Sponsor
Institute Chiba University
Institute
Department

Funding Source
Organization Chiba University
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
Email

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
2012 Year 01 Month 27 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
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
2011 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 01 Month 27 Day
Last modified on
2014 Year 01 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008426

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.