UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009631 |
|---|---|
| Receipt number | R000011301 |
| Scientific Title | Efficacy and safety of a selective neutrophil elastase inhibitor in surgery for patients with Crohn's disease: A randomized controlled study |
| Date of disclosure of the study information | 2012/12/26 |
| Last modified on | 2012/12/26 09:35:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy and safety of a selective neutrophil elastase inhibitor in surgery for patients with Crohn's disease: A randomized controlled study
Acronym
Efficacy and safety of a selective neutrophil elastase inhibitor in surgery for patients with Crohn's disease
Scientific Title
Efficacy and safety of a selective neutrophil elastase inhibitor in surgery for patients with Crohn's disease: A randomized controlled study
Scientific Title:Acronym
Efficacy and safety of a selective neutrophil elastase inhibitor in surgery for patients with Crohn's disease
Region
| Japan |
Condition
Condition
Crohn's disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the influence of perioperative administration of sivelestat on the incidence of surgical site infection
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Incidence of surgical site infection
Key secondary outcomes
Changes in T lymphocytes and inflammatory cytokines (IL-6 and IL-10)
Safety evaluation (adverse events and abnormal laboratory test values)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the intervention group, sivelestat sodium will be continuously administered intravenously at 4.8 mg/kg from introduction of anesthesia until a maximum of 2 days after surgery.
Interventions/Control_2
In the control group, sivelestat sodium will not be administered and conventional treatment will be given.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 16 years old or older at the time of obtaining consent
Patients who give written consent of their own free will after receiving a sufficient explanation of the study and fully understanding the study before participation.
Key exclusion criteria
Medical history of hypersensitivity to sivelestat
Age below 16 years old at the time of obtaining consent
Judgment of ineligibility to be a subject by the principle investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Kameoka |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery 2
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo,
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michio Itabashi |
Organization
Tokyo Women's Medical University
Division name
Department of Surgery 2
Zip code
Address
8-1 Kawada-cho, Shinjuku-ku, Tokyo,
TEL
03-3353-8111
Homepage URL
itabashi@surg2.twmu.ac.jp
Sponsor or person
Institute
Department of Surgery 2,Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery 2,Tokyo Women's Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 12 | Month | 26 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 02 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 12 | Month | 26 | Day |
Last modified on
| 2012 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011301
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
