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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009631
Receipt No. 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

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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
Email

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
Email itabashi@surg2.twmu.ac.jp

Sponsor
Institute Department of Surgery 2,Tokyo Women's Medical University
Institute
Department

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
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 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
URL(English) https://upload.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


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