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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004276
Receipt No. R000005129
Scientific Title Intrapleural administration of sustained-release basic fibroblast growth factor in patients with chronic obstructive pulmonary disease accompanied by pneumothorax
Date of disclosure of the study information 2010/12/01
Last modified on 2018/05/24

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Basic information
Public title Intrapleural administration of sustained-release basic fibroblast growth factor in patients with chronic obstructive pulmonary disease accompanied by pneumothorax
Acronym Intrapleural administration of sustained-release basic fibroblast growth factor in patients with chronic obstructive pulmonary disease accompanied by pneumothorax
Scientific Title Intrapleural administration of sustained-release basic fibroblast growth factor in patients with chronic obstructive pulmonary disease accompanied by pneumothorax
Scientific Title:Acronym Intrapleural administration of sustained-release basic fibroblast growth factor in patients with chronic obstructive pulmonary disease accompanied by pneumothorax
Region
Japan

Condition
Condition Chronic obstructive pulmonary disease accompanied by pneumothorax
Classification by specialty
Chest surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This is a single institute phase II study to investigate the effects of intrapleural administration of sustained-release basic fibroblast growth factor in patients with chronic obstructive pulmonary disease accompanied by pneumothorax.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Spirometry
Blood gas examination
Hugh-Jones score
Performance statis
Hospital stay
Recurrence free survival
Overall survival
CT value of lung
Key secondary outcomes

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 Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Sustained-release basic fibroblast growth factor (2.5 mg) diluted with fibrin glue solution is administrated to patients with chronic obstructive pulmonary disease accompanied by pneumothorax through chest drainage tube.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with chronic obstructive pulmonary disease accompanied by pneumothorax
Key exclusion criteria Patients with malignant tumors
Patients with intrapleural bacterial infection
Patients with allergy for gelatin
Patients with past history of side effect by trafermin
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tatsuya Yoshimasu
Organization Wakayama Medical University
Division name Department of Thoracic and Cardiovascular Surgery
Zip code
Address 811-1 Kimiidera, Wakayama, 641-8509, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tatsuya Yoshimasu
Organization Wakayama Medical University
Division name Department of Thoracic and Cardiovascular Surgery
Zip code
Address 811-1 Kimiidera, Wakayama, 641-8509, Japan
TEL 073-447-2300
Homepage URL
Email yositatu@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor Institute for Frontier Medical Sciences, Kyoto University
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 和歌山県立医科大学附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 12 Month 01 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
Finished.
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
2010 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 12 Month 01 Day
Last follow-up date
2018 Year 04 Month 30 Day
Date of closure to data entry
2018 Year 05 Month 31 Day
Date trial data considered complete
2018 Year 05 Month 31 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2010 Year 09 Month 28 Day
Last modified on
2018 Year 05 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005129

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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