UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008478 |
|---|---|
| Receipt number | 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 15:31:45 |
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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
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
atsuko_suzuki@terumo.co.jp
Sponsor or person
Institute
terumo corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009964
