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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028910
Receipt No. R000032997
Scientific Title Randomized Controlled Trial in efficacy and safety of E8002
Date of disclosure of the study information 2017/08/31
Last modified on 2018/05/18

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Basic information
Public title Randomized Controlled Trial in efficacy and safety of E8002
Acronym Randomized Controlled Trial in efficacy and safety of E8002
Scientific Title Randomized Controlled Trial in efficacy and safety of E8002
Scientific Title:Acronym Randomized Controlled Trial in efficacy and safety of E8002
Region
Japan

Condition
Condition Patients who are scheduled to undergo colostomy during laparotomy
Classification by specialty
Gastrointestinal surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of the investigational device (E8002) compared with active control during laparotomy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The evaluation of adhesions under the midline incision after surgery
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 E8002 (Adhesion Barrier)
Interventions/Control_2 Marketed product
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 who are aged 20 years or more on the day of signing the consent form
2)Patients undergoing a colectomy or proctectomy with a loop ileostomy or a loop colostomy under laparotomy (initial surgery), and are scheduled to undergo a colostomy closure or ileostomy closure 8 to 36 weeks after initial surgery (second surgery)
3)Patients who fully understand the nature of the trial and are able to give the informed consent
Key exclusion criteria 1)Patients with laparoscopy used in the initial surgery
2)Patients who have to be administrated the following drugs intraperitoneally from 24 hours pre-surgery to 7 days post-surgery:
steroids, heparin, low molecular weight heparin, salicylates, nonsteroidal anti-inflammatory drugs, Dextran 70, or antibiotic fluids
3)Patients who have a previous abdominal midline incision
4)Patients having a current diagnostic of peritonitis
5)Patients who currently have gastrointestinal perforation
6)Patients who are subject to emergency operation
7)Patients with metastatic cancers
8)Patients with ECOG performance status of 2 or greater
9)Patients who have severe drug allergy history
10)Patients who have specific drug allergy history to pullulan, poly (lactide-glycolide-caprolactone), ascorbic acid, sodium hyaluronate, and carboxymethyl cellulose
11)Patients who currently have systemic infections
12)Patients who are pregnant, lactating mothers, or wanting to become pregnant during clinical trials
13)Patients who are considered a life expectancy of less than one year
14)Patients who have participated in other interventional clinical trials within 30 days from the informed consent, or patients who are currently participating in other interventional clinical trials
15)Patients who have been determined as inappropriate for the trial by the investigator or subinvestigator
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sotaro Sadahiro
Organization Tokai University
Division name Department of Gastrointestinal Surgery
Zip code
Address 143 Shimokasuya Isehara, Kanagawa, Japan
TEL 0463-93-1121
Email sadahiro@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Tokunaga
Organization Research and Development Division
Division name Research and Development Division
Zip code
Address Shinagawa Intercity Tower B, 9th Floor 2-15-2, Konan, Minato-ku, Tokyo 108-6109, Japan
TEL 03-5769-2776
Homepage URL
Email P54_Clinical@kawasumi.jp

Sponsor
Institute Kawasumi Laboratories, Inc.
Institute
Department

Funding Source
Organization Kawasumi Laboratories, Inc.
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
2017 Year 08 Month 31 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 Open public recruiting
Date of protocol fixation
2017 Year 04 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 12 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
2017 Year 08 Month 30 Day
Last modified on
2018 Year 05 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032997

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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