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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000004364
Receipt No. R000005213
Scientific Title Efficasy of TJ-100 for gastrointestinal symptom of the patients after esophagectomy
Date of disclosure of the study information 2010/10/12
Last modified on 2010/10/10

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Basic information
Public title Efficasy of TJ-100 for gastrointestinal symptom of the patients after esophagectomy
Acronym TJ-100 study
Scientific Title Efficasy of TJ-100 for gastrointestinal symptom of the patients after esophagectomy
Scientific Title:Acronym TJ-100 study
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To measure an efficacy about gastrointestinal symptom of TJ-100 for the patienst after esophagectomy
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase I,II

Assessment
Primary outcomes Efficacy
Key secondary outcomes Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 TJ-100
Interventions/Control_2 no treatment
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
80 years-old >
Gender Male and Female
Key inclusion criteria operable esophageal cancer
Key exclusion criteria not emergency case
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akira Tangoku
Organization Tokushima University Hospital
Division name Department of Surgery
Zip code
Address 2-50-1Kuramoto chou, Tokushima city
TEL 088-633-7143
Email

Public contact
Name of contact person
1st name
Middle name
Last name Michi Miki
Organization The University of Tokushima graduate school
Division name Department of Thoracic, Endocrine surgery and Oncology
Zip code
Address 2-50-1Kuramoto chou, Tokushima city
TEL 088-633-7143
Homepage URL
Email surgery2@clin.med.tokushima-u.ac.jp

Sponsor
Institute Tokushima University Hospital
Institute
Department

Funding Source
Organization The University of Tokushima graduate school
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

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
2010 Year 10 Month 12 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 Preinitiation
Date of protocol fixation
2010 Year 10 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 11 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2014 Year 03 Month 01 Day
Date trial data considered complete
2014 Year 03 Month 01 Day
Date analysis concluded
2014 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 10 Month 10 Day
Last modified on
2010 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005213

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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