UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010810 |
|---|---|
| Receipt number | R000012593 |
| Scientific Title | A randomized controlled trials regarding perioperative management with oligopeptides(PN-2) in patients with lower gastrointestinal diseases. |
| Date of disclosure of the study information | 2013/07/01 |
| Last modified on | 2015/05/27 15:31:42 |
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Basic information
Public title
A randomized controlled trials regarding perioperative management with oligopeptides(PN-2) in patients with lower gastrointestinal diseases.
Acronym
Evaluations of the perioperative management with oligopeptides (PN-2).
Scientific Title
A randomized controlled trials regarding perioperative management with oligopeptides(PN-2) in patients with lower gastrointestinal diseases.
Scientific Title:Acronym
Evaluations of the perioperative management with oligopeptides (PN-2).
Region
| Japan |
Condition
Condition
lower gastrointestinal diseases
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety evaluation of oligopeptides (PN-2) in the perioperative patients with lower gastrointestinal diseases.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
We evaluate the safety of 'PN-2' by checking hematology,blood biochemistry, urine test and the adverse events by following CTCAE v4.0 index.
Evaluations as above are carried out three times,i.e.;seven days before surgery, just before surgery and about 10 days after surgery.
Key secondary outcomes
We evaluate the efficiency of 'PN-2' by checking the following indices: aminogram, immunological tests, wound hearing, complications and length of hospitalization.
Evaluations as above are carried out three times,i.e.; seven days before surgery, just before surgery and about 10 days after surgery.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Group A: ingestion
Patients group A ingest PN-2 three times per a day.
They are required to consecutive by ingest PN-2 for 7 days before surgery. In the same way, a consecutive intake of 7 days is required after surgery.
Interventions/Control_2
Group B: non-ingestion
Patients group B takes just a normal meal.
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 diagnosed with lower gastrointestinal diseases.
2) Patients expected over 3 month-survival from the first day of this study.
3) Patients who can orally ingestion.
4) Patients who are obtained with the prior written consent.
Key exclusion criteria
1) Patients with the following diseases.
(cirrhosis, chronic renal failure, diabetes with insulin therapy and so on)
2) Patients with steroid treatment
3) Patients with a disorder of amino acid metabolism.
4) Patients with food allergy.
5) Patients less than 20 years old.
6) Patients have experience of chemotherapy.
7) Patients judged to be inappropriate for this study from the doctor in charge.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshinori Ito |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Complementary and Alternative Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3498
juki@cam.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Asuka Yasueda |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Complementary and Alternative Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
06-6879-3498
Homepage URL
a-yasueda@cam.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Department of Complementary and Alternative Medicine
Institute
Department
Personal name
Funding Source
Organization
Saraya Co., Ltd.
Japan Food Peptide Institute inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Osaka General Medical Center Department of Digestive Surgery
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
大阪府立急性期・総合医療センター
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 01 | 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
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 10 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 11 | Month | 30 | Day |
Date analysis concluded
| 2014 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 27 | Day |
Last modified on
| 2015 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012593
