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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000008478
Receipt No. R000009964
Scientific Title Multi-institutional comparative test of TRM-108
Date of disclosure of the study information 2012/07/23
Last modified on 2014/01/20

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Basic information
Public title Multi-institutional comparative test of TRM-108
Acronym Multi-institutional comparative test of TRM-108
Scientific Title Multi-institutional comparative test of TRM-108
Scientific Title:Acronym Multi-institutional comparative test of TRM-108
Region
Japan

Condition
Condition Patients requiring a postoperative Total Parenteral Nutrition.
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To prove that Investigatinal Drug have similar efficacy in nutrition management to that of a Comparator, and to confirm its safety.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Total protein,Albumin,
Transferrin,Prealbumin,
Retinol Binding Protein
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization 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 TRM-108 Group
Take 24 hours to administer a one-days dose by continuous intravenous infusion via central vein.The administration period is 7 days.
Interventions/Control_2 FC Group
Take 24 hours to administer a one-days dose by continuous intravenous infusion via central vein.The administer period is 7 days.
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 (1)Patients aged at least 20 years.
(2)Patients requiring a postoperative Total Parenteral Nutrition.
(3)Patients who can give informed consent themelves betes mellitus or writing.
Key exclusion criteria (1)Investigators have juged that patient coresponds to any of the following.
lactic acidemia/addison's disease/oliguria/azotemia/hypothyroidism/hypothyroidism/heoatic coma or possibility of hepatic coma/defect in metabolism of amino asid/hemophiliac/medical historyl of hypersensitivity in any of the ingredient of investigational drug/electrolyte imbalance/severe liver damage/severe renal dysfunction/severe diabestesbmellitus or gucose metabolism disorder
(2)Woman during pregnancy or breastfeeding
(3)patient who have participated in another clinicaltrial trail whthin 6months beforths befor the
enrollment for this trial.
(4)Investigators have juged that patient have an inappropriate medical condition to particioate in this trial.
Target sample size 110

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Terumo corporation
Organization Terumo corporation
Division name Clinical Deveropment Department
Zip code
Address 1500 Inokuchi,Nakaima-mashi,ashigarakami-gun,kanagawa,Japan
TEL 0465-81-4104
Email atsuko_suzuki@terumo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Atsuko suzuki
Organization terumo corporation
Division name Clinical Development Department
Zip code
Address 1500 Inokuchi,Nakaima-mashi,ashigarakami-gun,kanagawa,Japan
TEL 0465-81-8488
Homepage URL
Email atsuko_suzuki@terumo.co.jp

Sponsor
Institute terumo corporation
Institute
Department

Funding Source
Organization terumo corpolation
Organization
Division
Category of Funding Organization Profit organization
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 07 Month 23 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 No longer recruiting
Date of protocol fixation
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 23 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 07 Month 20 Day
Last modified on
2014 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009964

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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