UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028910 |
|---|---|
| Receipt number | 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 | 2023/03/13 18:07:21 |
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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 | Sotaro |
| Middle name | |
| Last name | Sadahiro |
Organization
Tokai University
Division name
Department of Gastrointestinal Surgery
Zip code
259-1143
Address
143 Shimokasuya Isehara, Kanagawa, Japan
TEL
0463-93-1121
sadahiro@is.icc.u-tokai.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Tokunaga |
Organization
Research and Development Division
Division name
Research and Development Division
Zip code
108-6109
Address
Shinagawa Intercity Tower B, 9th Floor 2-15-2, Konan, Minato-ku, Tokyo 108-6109, Japan
TEL
03-5769-2776
Homepage URL
P54_Clinical@kawasumi.jp
Sponsor or person
Institute
Kawasumi Laboratories, Inc.
Institute
Department
Personal name
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
Tokai University Hospital Institutional Review Board
Address
143 Shimokasuya Isehara, Kanagawa, Japan
Tel
0463-93-1121
chiken@tokai-u.jp
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
151
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
| 2017 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
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
| 2023 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032997
