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Recruitment status Completed
Unique ID issued by UMIN UMIN000010810
Receipt No. 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

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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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Last 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
Email juki@cam.med.osaka-u.ac.jp

Public contact
1st 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
Email a-yasueda@cam.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Department of Complementary and Alternative Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012593


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