UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002404 |
|---|---|
| Receipt number | R000002949 |
| Scientific Title | Efficacy of Olprinone Hydrochloride During Pulmonary Resection for Lung Cancer |
| Date of disclosure of the study information | 2009/08/30 |
| Last modified on | 2013/08/30 13:55:03 |
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Basic information
Public title
Efficacy of Olprinone Hydrochloride During Pulmonary Resection for Lung Cancer
Acronym
Efficacy of Olprinone Hydrochloride During Lung Cancer Surgery
Scientific Title
Efficacy of Olprinone Hydrochloride During Pulmonary Resection for Lung Cancer
Scientific Title:Acronym
Efficacy of Olprinone Hydrochloride During Lung Cancer Surgery
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of olprinone hydrochloride during pulmonary resection for lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
whether infusion of olprinone hydrochloride during pulmonary resection has an effect on the reduction of postoperative atrial fibrillation
Key secondary outcomes
Anti-inflammatory effect
The change of perioperative cathecolamine levels after pulmonary resection
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Infusion of olprinone hydrochloride group
Interventions/Control_2
Control group
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who undergo pulmonary resection for lung cancer and preoperative BNP levels of 30pg/mL or more
Key exclusion criteria
None
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Nojiri |
Organization
Toneyama National Hospital
Division name
General Thoracic Surgery
Zip code
Address
Toneyama 5-1-1, Toyonaka City, Osaka 560-8552, Japan
TEL
06-6853-2001
nojiri@ri.ncvc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Nojiri |
Organization
Toneyama National Hospital
Division name
General Thoracic Surgery
Zip code
Address
Toneyama 5-1-1, Toyonaka City, Osaka 560-8552, Japan
TEL
06-6853-2001
Homepage URL
nojiri@ri.ncvc.go.jp
Sponsor or person
Institute
Toneyama National Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
国立病院機構刀根山病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 08 | Month | 30 | 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
Completed
Date of protocol fixation
| 2009 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 08 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 08 | Month | 30 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 30 | Day |
Last modified on
| 2013 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002949
