UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004276 |
|---|---|
| Receipt number | 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 11:33:46 |
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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
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
yositatu@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005129
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
