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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000003295
Receipt No. R000003990
Scientific Title Phase I study for the efficacy and the safety of the perioperative urinastatin therapy in chest surgical patients with interstitial pneumonia.
Date of disclosure of the study information 2010/03/06
Last modified on 2010/03/06

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Basic information
Public title Phase I study for the efficacy and the safety of the perioperative urinastatin therapy in chest surgical patients with interstitial pneumonia.
Acronym Phase I study for the perioperative urinastatin therapy in chest surgical patients with interstitial pneumonia
Scientific Title Phase I study for the efficacy and the safety of the perioperative urinastatin therapy in chest surgical patients with interstitial pneumonia.
Scientific Title:Acronym Phase I study for the perioperative urinastatin therapy in chest surgical patients with interstitial pneumonia
Region
Japan

Condition
Condition interstitial pneumonia, lung cancer,
metastatic lung tumor, pneumothorax
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We are going to evaluate the safety and efficacy of perioperative ulinastatin therapy for chest surgical patient including lung tumor, lung cancer, and others with interstial pneumonia.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Judging whether a side effect of the ulinastatin appeared.
Evaluating the kind of the side effect, frequency, grade of the ulinastatin.
Key secondary outcomes Judging whether acute exacerbation of the postoperative interstitial pneumonia appeared.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 From the 2nd day before an operation, ulinastatin was administered as a 30 min infusion of 300000 U for 3 consecutive days. The dose of the ulinastatin reduced by 100000 unit every 3rd day.
Interventions/Control_2
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.Preoperative chest CT scans IP findings were checked by a radiologist.
The criteria for identifying IPF on a chest high-resolution computed tomography (HRCT) were subpleural space shadow, honeycomb formation, reticular shadow, tractional bronchitis/bronchioles etc., and consolidation.
2.IP findings such as fine crackles at the bilateral lower lung were checked by a pulmonologist.
3.Performance status of 0 to 1
4.The functions of the main organs such as bone marrow, heart, liver, and kidney are kept. Within 2 weeks before registration, the criteria are follows.
White blood cell count
>=3000mm3-<=12000mm3
Neutrophil count
>=1500mm3-<=5000mm3
Platelet count >=50000mm3
Hemoglobin >=8g/dL
Serum KL-6 >=500U/mL
Aspartate aminotransferase (AST) and
Alanine aminotransferase (ALT);
2 times upper limit of normal in our
hospital
5.A case that an operation under the general anesthesia is possible.
6.A case that a document agreement by the person himself was provided about examination participation.
Key exclusion criteria 1.Having the history of allergic reaction against ulinastatin.
2.Asbestosis.
3.Chronic hypersensitivity pneumonitis.
4.Sarcoidosis.
5.Pregnancy.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Onuki Takamasa
Organization Tokyo Women's Medical University of Medicine
Division name Department of Surgery I
Zip code
Address 8-1Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokyo Women's Medical University of Medicine
Division name Department of Surgery I
Zip code
Address 8-1Kawada-cho, Shinjuku-ku, Tokyo
TEL 03-3353-8111
Homepage URL
Email

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

Funding Source
Organization Tokyo Women's Medical University of Medicine, Department of Surgery I
Organization
Division
Category of Funding Organization Self funding
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
2010 Year 03 Month 06 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
2009 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2010 Year 03 Month 01 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
2010 Year 03 Month 06 Day
Last modified on
2010 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003990

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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